USFDA Approved Biosimilars
In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve Biosimilars to those biologics originally approved through the PHS Act pathway. Since 2004 the FDA has held a series of public meetings on Biosimilars. The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin originally approved as a biologic drug under the FD&C Act.
Related Conference of USFDA Approved Biosimilars
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USFDA Approved 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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