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s B, BS A K, PM H. Emerging Trends in Biologic Drugs and Biosimilars. pbp 2025; 7 (In press)
URL: http://pbp.medilam.ac.ir/article-1-312-en.html
URL: http://pbp.medilam.ac.ir/article-1-312-en.html
1- R L Jalappa College of Pharmacy, Sri Devaraj Urs Academy Higher Education and Research (A Deemed to be University), Tamaka, Kolar-563103, India. , bhargavi.sklr123@gmail.com
2- R L Jalappa College of Pharmacy, Sri Devaraj Urs Academy Higher Education and Research (A Deemed to be University), Tamaka, Kolar-563103, India.
2- R L Jalappa College of Pharmacy, Sri Devaraj Urs Academy Higher Education and Research (A Deemed to be University), Tamaka, Kolar-563103, India.
Abstract: (245 Views)
Objective: Biologic medications have greatly improved the management of complex and chronic illnesses by providing targeted, specific, and less-toxic therapies in comparison to traditional small-molecule medications. These protein-based, large therapies derived from living organisms are at the forefront of managing cancer, autoimmune diseases, and orphan diseases. As the patents for key biologics expire, biosimilars—hypothesized copies that are very similar and cheaper—are becoming increasingly important as a plausible alternative, improving affordability and treatment access.
Methodology: The review aggregates current peer-reviewed journals, international regulatory guidelines, and pharmaceutical market reports released between 2015 and 2025. The review targets technological advancements, regulatory updates, and market trends that affect biologics and biosimilars. Sources were picked on grounds of relevance, credibility, and additive value towards the dynamic trend of biopharmaceuticals.
Results: Emerging technologies like monoclonal and bispecific antibodies, gene therapy, and cell-based therapies are broadening the therapeutic applications of biologics. Adoption of biosimilars is growing across the world, especially in Europe, with gathering momentum in the United States and developing nations. Bodies like the FDA and EMA have launched formalized approval pathways to ascertain biosimilar safety and efficacy. Nonetheless, regulatory hurdles remain in production, immunogenic risk, and gaining wider market acceptance.
Conclusion: Biologics and biosimilars are the wave of the future in disease management, promising new solutions for daunting health problems. Despite regulatory and production hurdles, further innovation in biotechnology and public policy can be anticipated to propel their broad implementation. They have the potential to improve patient outcomes and lower health care costs globally.
Methodology: The review aggregates current peer-reviewed journals, international regulatory guidelines, and pharmaceutical market reports released between 2015 and 2025. The review targets technological advancements, regulatory updates, and market trends that affect biologics and biosimilars. Sources were picked on grounds of relevance, credibility, and additive value towards the dynamic trend of biopharmaceuticals.
Results: Emerging technologies like monoclonal and bispecific antibodies, gene therapy, and cell-based therapies are broadening the therapeutic applications of biologics. Adoption of biosimilars is growing across the world, especially in Europe, with gathering momentum in the United States and developing nations. Bodies like the FDA and EMA have launched formalized approval pathways to ascertain biosimilar safety and efficacy. Nonetheless, regulatory hurdles remain in production, immunogenic risk, and gaining wider market acceptance.
Conclusion: Biologics and biosimilars are the wave of the future in disease management, promising new solutions for daunting health problems. Despite regulatory and production hurdles, further innovation in biotechnology and public policy can be anticipated to propel their broad implementation. They have the potential to improve patient outcomes and lower health care costs globally.
Keywords: Biologic drugs, monoclonal antibodies, gene therapy, precision medicine, Regulatory landscape
Type of Study: Review/Systemtic review |
Subject:
Biotechnology
Received: 2025/05/27 | Accepted: 2025/05/31 | Published: 2025/12/1
Received: 2025/05/27 | Accepted: 2025/05/31 | Published: 2025/12/1
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