Monoclonal Antibody Biosimilars
The first mAb biosimilars to be approved in Europe and elsewhere was the infliximab biosimilars (Inflectra and Remsima), which originator is Remicade. In October 2013, after the European Medicines Agency (EMA) gave a positive opinion for infliximab biosimilars, the European Commission granted a marketing authorization (MA) for these two biosimilars in the various therapeutic indications that are authorized for Remicade (i.e. indications in gastroenterology, rheumatology, and dermatology). As for previously approved biosimilars, the two aforementioned European institutions did not make a stand on the issues of substitution, and with good reason, as answering these questions does not fall within their areas of expertise and is the sole responsibility of EU Member States.
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Monoclonal Antibody Biosimilars Conference Speakers
Recommended Sessions
- BCS and IVIVC Based Biowaivers
- Biological Medicine
- Biopharmaceutical Informatics
- Biosimilars Approval to Biogenerics in Clinical Practice
- Biosimilars Development in Markets
- Biosimilars Market and Cost Analysis
- Biosimilars Research Pipeline
- Challenges in Biosimilars Pharmacovigilance
- Chemical and Analytical Strategies for Biosimilars
- Consequences of Brexit on Biosimilars
- Current Agency Expectations for Approval for Biosimilars
- Current Challenges in Developing Biosimilars
- Drug Delivery and Development
- Emerging Biosimilars in Therapeutics
- Formulation Strategies for Follow-on Biologics
- Globalization of Biosimilars
- Innovative Clinical Approach in Biosimilars
- Intellectual Property Rights
- Legal Issues and BPCI Act
- Monoclonal Antibody Biosimilars
- Regulatory Updates on Biosimilars
- USFDA Approved Biosimilars
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- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)