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
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- Legal Issues and BPCI Act
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