Pharmaceutical and Biopharmaceutical Industries: Revolutionizing Healthcare

The drug and biopharmaceutical enterprises play a pivotal part in transforming healthcare through the incident and delivery of creative cures and remedies. This item explores the key facets of these areas, stressing their impact on healthcare.

Pharmaceuticals, outlined as wealthy secondhand in the diagnosis, situation, or stop of disease, aim to restore, correct, or refine everyday functions. On the other hand, biopharmaceuticals (or biologicals) circumscribe sugars, proteins, nucleic acids, living containers, or tissues and are curative devices that arise natural beginnings to a degree persons, animals, or microorganisms. In contrast to common pills combined with synthetic processes, biopharmaceuticals are primarily acquired through unaffected processes, containing extraction from living constructions or production utilizing alteration of genetic material Table 1.

• Some usual biopharmaceuticals, originally gleaned from animals or persons, are immediately created through biotechnological advancements.
• For instance, healing insulin, previously gleaned from porcine pancreatic islets, is immediately made utilizing alteration of genetic material in yeast (Saccharomyces cerevisiae) or E. coli.
• Biopharmaceuticals caused by alteration of genetic material usually fall into three classifications:
• Substances nearly equal to the body’s own key signaling proteins.
• Monoclonal antibodies look like those caused by apiece human immune plan against bacteria.
• Receptor builds (fusion proteins) established uniformly happening receptors connected to the immunoglobulin frame.

Examples include

From living systems: Whole blood and ancestry parts, organs and fabric transplants, stem containers, antibodies for inactive immunization, polluted microbiota, human bosom milk, and human reproductive containers.

Produced by recombinant DNA: Blood determinants, fabric plasminogen activators, hormones, hematopoietic growth determinants, interferon, interleukin-located produce, vaccines, monoclonal antibodies, tumor loss determinants, therapeutic enzymes.

• Key dispute Pharmaceutical manufacturing
• Biopharmaceuticals
• Healthcare strike
• Innovative medicines
• Therapeutic fragments
• Recombinant DNA technologies
• Personalized cure
• Gene medicines
• Regulatory processes

The pharmaceutical and biopharmaceutical businesses play important roles in numbering healthcare by concentrating on the finding, development, and result of drugs that treat and hamper afflictions. This article investigates key facial characteristics of two industries and their deep effects on healthcare.

1. Pharmaceutical industry

Pharmaceutical manufacturing is a versatile area that encompasses miscellaneous stages from testing to production and distribution.

1. Research and Development (R&D): Pharmaceutical guests densely invest in R&D to label new drugs, including the finding of potential drug targets and preclinical studies.
2. Clinical trials: Rigorous dispassionate tests determine safety, productiveness, and portion of drug or other consumables, including human volunteers and absolute pacts to ensure patient security.
3. Regulatory approval: Regulatory instrumentalities, to a degree the FDA, rigorously investigate drugs for security, productiveness, and quality before retail authorization based on inclusive dispassionate trial dossier.
4. Manufacturing and distribution: Companies maintain cosmopolitan production abilities with accurate control of product quality, ensuring agreeing and cautious drug results. Efficient distribution networks guarantee a prompt approach to medicines.

2. Biopharmaceuticals industry

Biopharmaceuticals manufacturing focuses on cures that arise from biological beginnings, engaging advanced biotechnological processes.

1. Biotechnology: Biopharmaceuticals are created through alteration of genetic material, alteration of genetic material, and cell idea methods, permissive the creation of complex and mean medicines.
2. Personalized medicine: Biopharmaceuticals enable embodied cure, adjusting treatments to an individual's historical cosmetics and affliction characteristics for embellished efficiency and minimal unfavorable belongings.
3. Biosimilars: The manufacturing has developed biosimilars, providing economical substitutes accompanying comparable efficiency and security sketches to approved drug drugs.
4. Immunotherapy and gene therapy: Biopharmaceuticals have transformed cancer situations through immunotherapies, leveraging the invulnerable structure. Gene therapies hold promise for inherited disorder situations.

3. Impact on healthcare

Both businesses have profoundly jolted healthcare by presenting innovative drugs and remedies.

1. Disease treatment and prevention: Innovative drugs have supported active treatments for earlier untreatable environments, considerably improving patient effects.
2. Extended lifespan: Pharmaceutical progress addressing incessant afflictions causes increased longevity and revised overall energy outcomes.
3. Economic growth and job creation: The drug and biopharmaceutical subdivisions significantly influence worldwide economic tumors by creating recruitment opportunities. These commerces are a part of essential pillars advocating business-related development.
4. Research and collaboration: These businesses energetically advance scientific research and support cooperation between academia, manufacturing, and healthcare providers. Such cooperation facilitates the exchange of information, superior to constant advancements in healing skills.

The European Medicines Agency (EMA) takes advantage of the term “advanced medicine curative products (ATMPs)” to classify human drugs’ established containers, genes, or tissue architecture. This contains Cell Therapy Products (CTPs), which are biomedicines containing maneuvered containers or tissues for treating, forestalling, or diagnosing ailments [1]. Gene Therapy Products (GTPs) include genetic modifications, in the way that repair, erasure, insert, or substitution of mutated genes for target healing purposes [2]. Tissue engineering integrates container, construction, and material methods to reinforce, repair, or change prejudiced or entire organic tissues, containing bones, pieces of animate skeleton, ancestry ships, organs, skin, influences, etc. The process can again utilize the fabric stage for forming potential new tissues for healing uses [3-5].

A biosimilar, likewise referred to as an “understand-on drug,” is a drug medical merchandise almost identical to other merchandise created by a various pharmaceutical party. While minor alternatives in clinically lazy components grant permission, there are no clinically important distinctnesses in agreements of safety, innocence, and effectiveness middle from two points biosimilars and reference output. Unlike general drugs that are identical to brand-name drugs, biosimilars withstand exact experiments to ensure their similarity to the inventor crop. Generic drugs must contain the alike alive pharmaceutical additives (APIs) in the same quantities as the brand-name amount and demonstrate bioequivalence. In contrast, biosimilars, like general drugs, may be made once the patent for the original “inventor” merchandise expires and are officially certified histories of the original brand [6]. However, there are notable prominences betwixt settled drugs and biosimilars. While both exhibit equivalent dispassionate belongings, biosimilars differ from common drugs as their APIs are not equal to the remark products. Despite this variety, two general drugs and biosimilars must maintain logical features and performance during the whole of their history eras [7].

“Biosimilars are defined and explained for their financial and dispassionate implications in current magazines, regulations, and the US FDA counseling registry. They concede the possibility of replacing a few biopharmaceuticals accompanying more inexpensive biosimilars when they lose patent guardianship. However, different generic drugs and biosimilars are despite everything the remark production in shape and function [8-21].”

Therapy

Therapeutic biopharmaceuticals contain differing modalities in the way that recombinant protein medicine, microscopic organism cure, cellular healing, and deoxyribonucleic acid analysis. These biopharmaceuticals efficiently treat diseases by professed organic exercises and guide specific determinants in the affliction’s pathophysiology. Despite being disputing to produce, bearing multiple routes of presidency, and obvious pharmacokinetics distinguished from chemical drugs, biopharmaceuticals offer benefits to a degree of extreme discrimination and low remiss toxicity. However, their exercise can require high costs and the risk of encouraging antagonistic-drug antibodies, conceivably superior to reduced productiveness or biosafety concerns. Optimization of the situation is attainable through enhanced drug schedules and different policy-making routes, while cost decline can be realized through the use of biosimilars.

Prevention

Vaccines, important biopharmaceuticals, play a principal duty in preventing the spreading of ailments. Typically collected of unrefined agents looking like pathogens, vaccines are from inactivated or weakened bacteria, toxoids, or segments of surface antigens. Vaccination has considerably decreased the predominance of infectious afflictions in the way that measles, nervous system infection, and polio and has even experienced the eradication of smallpox. However, the burden of noninfectious afflictions like cancers, cardiovascular afflictions, metabolic ailments, and neurodegenerative afflictions is increasing. Some vaccines, like the human papillomavirus (HPV) cure, efficiently hinder cancers.

Diagnosis

In addition to their healing and preventive parts, biopharmaceuticals help disease disease. Monoclonal antibodies, e.g., have been favorably employed in the evaluation of cancers and catching afflictions, accompanying ongoing incidents. Once monoclonal antibodies guide an element are created, they can identify and discover this meaning, making the ruling class valuable in methods like immunohistochemistry for detecting antigens in normal fabric divisions or containers.

Perspective and challenge

The field of biopharmaceuticals is rapidly developing, giving new paths for human analysis. Researchers actively undertake evolving creative biopharmaceuticals accompanying promising dispassionate and supervisory prospects. Despite these progresses, challenges endure, both in controlled and supervisory rules. Scientific challenges involve the growth of biotechnologies, superior to a raised array of novel biopharmaceuticals for different clinical requests. While biopharmaceuticals are widely handled for ailment control, stop, and diagnosis, few uncertain controlled challenges lie.

Vaccine

Vaccination, considered an optimum game plan for ailment control, faces challenges in the way that strict depository necessities, restricted routes of administration, and the need for supporter shots. Nanotechnology arises as a potential resolution to defeat consumption and aftereffects, admitting vaccines expected executed in different areas, stocked at range hotness, and offering alternative presidency routes. Challenges contain nanoparticle toxicity and invulnerable reactions, though the development of referring to practices or policies that do not negatively affect the environment and biocompatible nanoparticles shows promise.

Gene therapy

While many Cell Therapy Products (CTPs) have been authorized and are widely used, deoxyribonucleic acid cures are mainly in exploratory stages. Advances in genetic engineering authorize genome guidance, and differing transfer systems, in the way that lipids, viruses, microorganisms, and nanoparticles, have existed and grown. However, challenges include guaranteeing particularity, adeptness, biosafety, and addressing business-related restraints in the test of childbirth systems. Limited lures for biotechnology guests deter the investigation of novel delivery forms on account of extreme enlightening risks and constrained profits.

Overcoming challenges in gene therapy delivery

In current studies, important progress has happened and worked out to address challenges in delivering Gene Therapy Products (GTPs) in vivo [19-22] Table 2.

Possible Techniques for Overcoming Challenges in Drug Delivery (named in Table 2. Potential Application of the CRISPR/Cas9 System towards Herpes Virus Infections. Viruses. 2018 May 29; 10 (6). PII: E291. Abbreviation: assembled daily inter-spaced short palindromic repeats.

Regular issues: Biopharmaceuticals pose unique supervisory challenges on account of their normal beginning, abundant molecular diameter, fundamental complicatedness, and incidental nervousness. These challenges are evident in differing stages to a degree research, results, dispassionate tests, applications, and shopping. Notwithstanding settled tactics and foundations, distinguishing regulatory issues stand for container cure, deoxyribonucleic acid remedy, and biosimilars.

Cell therapy and gene therapy

CTPs and GTPs have the style to be commodified because of the actuality many producers are aiming at pursuing agency interests. Commercial advertising and marketing of unsupported therapeutics making use of CTPs and GTPs is a world assignment that has validated resistance to regulatory efforts. I tried some unapproved or unproved CTPs and GTPs on victims totally from their indefinite perspectives. Some CTPs and GTPs whose medical trials or data are incomplete are in enchantment launched on the market completely because of giant interests. A coordinated method at the countrywide and world levels headquartered on engagement, harmonization, and enforcement has to be carried out to limit the dangers associated with direct client advertising and marketing of unapproved or unproven CTPs and GTPs [23]. However, sometimes, some CTPs or GTPs have no longer alternatively achieved their efficacy validation. Alternatively, they have sufficient information to confirm their protection and estimate their efficacy. For the remedy of patients who are in serious stipulations or have unmet scientific needs, precise CTPs or GTPs can be reachable to these victims with adaptive licensing. The regulator desires to set up a conditional approval device in the guidelines with a deadline, a fast-track review, and a dialog mechanism to have victims press pick to take precise CTPs GTPs as quickly as possible. CRISPRs)/Cas9 nuclease system.

Biosimilar

As a product of living organisms, biopharmaceuticals are more difficult than small molecular-weight chemical tablets because of their sensitivity to manufacturing procedures and post-translational modifications. Most facts on the manufacturing manner are no longer utterly open to the public because they might also be proprietary or patent. This data hole stands for an indispensable undertaking for biosimilar builders and performs an imperative position in explaining the variations in regulatory pathways. It is required to exhibit similarity and guarantee that the alternate in the manufacturing system represents no consequences for security and efficacy. The extent of the exchange is normally a key indicator of the evaluation required to consider the quality.

Way of regulators has addressed otherwise Biosimilarity workouts to recognize that biosimilar builders start with essential variations together with traditional media, purification processes, and formulations [24]. Therefore, it is required to make sure that the modifications no longer impact the efficacy and security of biosimilars.

Biosimilars are described and existing their economic and scientific implications in contemporary publications, regulations, and the US FDA coaching archives. It may also change some biopharmaceuticals with more cost-effective biosimilars when they lose patent protection. However, not like familiar drugs, biosimilars are distinct from the reference merchandise in shape and function. The US Biologics Price Competition and Innovation (BPCI) Act of 2009 created an abbreviated licensure pathway to enable the improvement and approval of biosimilars and interchangeable reference merchandise that are licensed [25,26]. The US FDA can approve biosimilars through the abbreviated licensure pathway under the BPCI Act. Biosimilars permitted in Europe are solely composed of easy and small molecules. Complex and large-molecule biosimilars will be subjected to an extra rigorous and extended approval manner. The economic success of biopharmaceutical remedies and their patent expiration finally resulted in the improvement of biosimilars. The pharmaceutical corporation has to advance complicated biosimilars that mimic the authentic “innovator” tablets and discover analytical strategies to display similarity to regulatory authorities. A remark outlines the efforts of a built-in fitness machine to ensure biosimilar accessibility and discusses the innovative challenges and future implications. Biosimilars confront regulatory challenges on plausible implications for pricing, web pages of care, and pharmacy doling out practices [27]. We trust biosimilars are beneficial to the healthcare system, however, their expected advantages might also not be understood in the close to future.

Literature review

Conduct a thorough drama review to comprehend the current state of the pharmaceutical and biopharmaceutical labors, their effect on healthcare, and current progress. Identify key flows, challenges, and moments in the pharmaceutical and biopharmaceutical areas.

Data collection

Collect dossier from esteemed beginnings to a degree scientific journals, manufacturing reports, and administration advertisements. Utilize databases like PubMed, Science Direct, and supervisory instrumentalities’ websites to gather appropriate news. Include a dossier on drug growth processes, supervisory necessities, and market movement.

Case studies

Analyze case studies of favorable drugs and biopharma-ceutical devices to think of factors donating to their achievement.

Examine challenges confronted all along, supervisory approval, and commercialization.

Surveys and interviews

Conduct surveys with pros in the drug and biopharmaceutical businesses to draw insights on current practices, challenges, and arising currents.

Interview key colleagues, including scientists, supervisory experts, and manufacturing managers, to gain meticulous views.

Quantitative analysis

Utilize mathematical methods to resolve determinable dossier, in a way that displays currents, R&D investments, and drug authorization rates.

Apply appropriate mathematical tests to label important equivalences and patterns.

Drug development innovations

Discuss innovations in drug incident processes, containing extreme-throughput protection, accuracy medicine, and the use of machine intelligence. Highlight progress in biopharmaceuticals, to a degree monoclonal antibodies, deoxyribonucleic acid analyses, and container therapies.

Regulatory landscape

Analyze the progressing supervisory countryside and allure affect the pharmaceutical and biopharmaceutical labors.

Discuss the challenges and events formally by supervisory changes and their suggestions for healthcare.

Market dynamics

Present a particularized analysis of advertising action, containing display content, growth projections, and key chauffeurs doing the drug and biopharmaceutical subdivisions.

Discuss the impact of all-encompassing events, to a degree epidemic, on retail flows and supply chain movement.

Challenges and opportunities

Identify challenges confronted by the drug and biopharmaceutical enterprises, in the way that drug valuing, supervisory hurdles, and competition.

Discuss freedom for tumor, cooperation, and change inside the manufacturing.

Impact on healthcare

Evaluate the overall impact of the pharmaceutical and biopharmaceutical commerces on healthcare consequences and patient welfare.

Discuss by what method progresses in these industries help the stop, situation, and administration of miscellaneous ailments.

Future perspectives

Provide insights into future styles and incidents in the drug and biopharmaceutical subdivisions.

Discuss potential breakthroughs, arising technologies, and extents for further research.

The pharmaceutical and biopharmaceutical industries play a pivotal role in healthcare transformation by means of pioneering revolutionary remedies. Biopharmaceuticals, with their specific characteristics, hold exceptional promise for sickness management and prevention, surpassing the competencies of traditional drugs. Ongoing studies are developing novel biopharmaceuticals that might discover applications in medical settings within the near destiny. regardless of the progress, certain unresolved scientific and regulatory demanding situations persist. The authors anticipate that persistent efforts in the discovery, production, application, and addressing challenges will yield fruitful effects, substantially impacting human health.

The accomplishment of this research project would not have existed without the offerings and support of many things and institutions. grateful We are intensely grateful to all those who performed a function for the benefit of this project We too thank my mentors, Naweed Imam Syed, Prof. Department of Cell Biology at the University of Calgary, and Dr. Sadaf Ahmed Psychophysiology Lab, University of Karachi, for their priceless recommendations and support during the whole of this research. Their observations and knowledge assisted in forming the management concerning this project.

1. Chen YC, Cheng HF, Yeh MK. Cell Therapy Regulation in Taiwan. Cell Transplant. 2017 Mar 13;26(3):483-492. doi: 10.3727/096368916X693293. Epub 2016 Sep 30. PMID: 27697103; PMCID: PMC5657697.
2. Gonçalves GAR, Paiva RMA. Gene therapy: advances, challenges and perspectives. Einstein (Sao Paulo). 2017 Jul-Sep;15(3):369-375. doi: 10.1590/S1679-45082017RB4024. PMID: 29091160; PMCID: PMC5823056.
3. Marei MK, El Backly RM. Dental Mesenchymal Stem Cell-Based Translational Regenerative Dentistry: From Artificial to Biological Replacement. Front Bioeng Biotechnol. 2018 May 2;6:49. doi: 10.3389/fbioe.2018.00049. PMID: 29770323; PMCID: PMC5941981.
4. Shoji T, Shinoka T. Tissue engineered vascular grafts for pediatric cardiac surgery. Transl Pediatr. 2018 Apr;7(2):188-195. doi: 10.21037/tp.2018.02.01. PMID: 29770300; PMCID: PMC5938251.
5. Stephenson M, Grayson W. Recent advances in bioreactors for cell-based therapies. F1000Res. 2018 Apr 30;7:F1000 Faculty Rev-517. doi: 10.12688/f1000research.12533.1. PMID: 29770207; PMCID: PMC5931275.
6. Nick C. The US Biosimilars Act: Challenges handling supervisory authorization. Pharmaceutical Medicine. 2012; 26 (3):145-152. DOI: 10.1007/bf03262388.
7. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014 Aug;3(4):889-99. doi: 10.1002/cam4.258. Epub 2014 May 9. PMID: 24810680; PMCID: PMC4303156.
8. Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, Seidl A, Schiestl M. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opin Biol Ther. 2018 Apr;18(4):369-379. doi: 10.1080/14712598.2018.1421169. Epub 2018 Jan 10. PMID: 29285958.
9. Strati P, Jain N, O'Brien S. Chronic Lymphocytic Leukemia: Diagnosis and Treatment. Mayo Clin Proc. 2018 May;93(5):651-664. doi: 10.1016/j.mayocp.2018.03.002. PMID: 29728204.
10. Marr KA, Datta K, Mehta S, Ostrander DB, Rock M, Francis J, Feldmesser M. Urine Antigen Detection as an Aid to Diagnose Invasive Aspergillosis. Clin Infect Dis. 2018 Nov 13;67(11):1705-1711. doi: 10.1093/cid/ciy326. PMID: 29684106; PMCID: PMC6233688.
11. Phuong NH, Kwak C, Heo CK, Cho EW, Yang J, Poo H. Development and Characterization of Monoclonal Antibodies against Nucleoprotein for Diagnosis of Influenza A Virus. J Microbiol Biotechnol. 2018 May 28;28(5):809-815. doi: 10.4014/jmb.1801.01002. PMID: 29642295.
12. Chen YC, Cheng HF, Yang YC, Yeh MK. Nanotechnologies secondhand in biomedical vaccines. In: Stanciu SG, redactor. Micro and Nanotechnologies for Biotechnology. Rijeka, Croatia: InTech; 2016; 85-105. DOI: 10.5772/63453.
13. Chen YC, Cheng HF, Yang YC, Yeh MK. Biotechnologies secondhand in biomedical vaccines. In: Afrin F, Hemeg H, Ozbak H, editors. Vaccine. Rijeka, Croatia: InTech; 2017; 97-110. DOI: 10.5772/intechopen.69547.
14. Das SK, Menezes ME, Bhatia S, Wang XY, Emdad L, Sarkar D, Fisher PB. Gene Therapies for Cancer: Strategies, Challenges and Successes. J Cell Physiol. 2015 Feb;230(2):259-71. doi: 10.1002/jcp.24791. PMID: 25196387; PMCID: PMC4363073.
15. Bai Y, Gong H, Li H, Vu GP, Lu S, Liu F. Oral delivery of RNase P ribozymes by Salmonella inhibits viral infection in mice. Proc Natl Acad Sci U S A. 2011 Feb 22;108(8):3222-7. doi: 10.1073/pnas.1014975108. Epub 2011 Feb 7. PMID: 21300908; PMCID: PMC3044408.
16. Gan WB, Grutzendler J, Wong WT, Wong RO, Lichtman JW. Multicolor "DiOlistic" labeling of the nervous system using lipophilic dye combinations. Neuron. 2000 Aug;27(2):219-25. doi: 10.1016/s0896-6273(00)00031-3. PMID: 10985343.
17. Guo W, Guo Y, Tang S, Qu H, Zhao H. Dendritic cell-Ewing's sarcoma cell hybrids enhance antitumor immunity. Clin Orthop Relat Res. 2008 Sep;466(9):2176-83. doi: 10.1007/s11999-008-0348-7. Epub 2008 Jun 19. PMID: 18563501; PMCID: PMC2493000.
18. Stewart MP, Sharei A, Ding X, Sahay G, Langer R, Jensen KF. In vitro and ex vivo strategies for intracellular delivery. Nature. 2016 Oct 13;538(7624):183-192. doi: 10.1038/nature19764. PMID: 27734871.
19. Oggu GS, Sasikumar S, Reddy N, Ella KKR, Rao CM, Bokara KK. Gene Delivery Approaches for Mesenchymal Stem Cell Therapy: Strategies to Increase Efficiency and Specificity. Stem Cell Rev Rep. 2017 Dec;13(6):725-740. doi: 10.1007/s12015-017-9760-2. PMID: 28815481.
20. Xiao Q, Min T, Ma S, Hu L, Chen H, Lu D. Intracellular generation of single-strand template increases the knock-in efficiency by combining CRISPR/Cas9 with AAV. Mol Genet Genomics. 2018 Aug;293(4):1051-1060. doi: 10.1007/s00438-018-1437-2. Epub 2018 Apr 18. PMID: 29671068.
21. Finn JD, Smith AR, Patel MC, Shaw L, Youniss MR, van Heteren J, Dirstine T, Ciullo C, Lescarbeau R, Seitzer J, Shah RR, Shah A, Ling D, Growe J, Pink M, Rohde E, Wood KM, Salomon WE, Harrington WF, Dombrowski C, Strapps WR, Chang Y, Morrissey DV. A Single Administration of CRISPR/Cas9 Lipid Nanoparticles Achieves Robust and Persistent In Vivo Genome Editing. Cell Rep. 2018 Feb 27;22(9):2227-2235. doi: 10.1016/j.celrep.2018.02.014. PMID: 29490262.
22. Lau CH, Suh Y. In vivo genome editing in animals using AAV-CRISPR system: applications to translational research of human disease. F1000Res. 2017 Dec 20;6:2153. doi: 10.12688/f1000research.11243.1. PMID: 29333255; PMCID: PMC5749125.
23. Sipp D, Caulfield T, Kaye J, Barfoot J, Blackburn C, Chan S, De Luca M, Kent A, McCabe C, Munsie M, Sleeboom-Faulkner M, Sugarman J, van Zimmeren E, Zarzeczny A, Rasko JEJ. Marketing of unproven stem cell-based interventions: A call to action. Sci Transl Med. 2017 Jul 5;9(397):eaag0426. doi: 10.1126/scitranslmed.aag0426. PMID: 28679655.
24. Declerck P, Farouk-Rezk M, Rudd PM. Biosimilarity Versus Manufacturing Change: Two Distinct Concepts. Pharm Res. 2016 Feb;33(2):261-8. doi: 10.1007/s11095-015-1790-3. Epub 2015 Sep 17. PMID: 26381277.
25. Epstein MS, Ehrenpreis ED, Kulkarni PM; FDA-Related Matters Committee of the American College of Gastroenterology. Biosimilars: the need, the challenge, the future: the FDA perspective. Am J Gastroenterol. 2014 Dec;109(12):1856-9. doi: 10.1038/ajg.2014.151. Epub 2014 Jun 24. PMID: 24957160.
26. Dougherty MK, Zineh I, Christl L. Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States. Clin Pharmacol Ther. 2018 Jan;103(1):36-38. doi: 10.1002/cpt.909. Epub 2017 Nov 20. PMID: 29152721.
27. Peterson J, Budlong H, Affeldt T, Skiermont K, Kyllo G, Heaton A. Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape. J Manag Care Spec Pharm. 2017 Dec;23(12):1255-1259. doi: 10.18553/jmcp.2017.23.12.1255. PMID: 29172981; PMCID: PMC10398052.