On the Regulatory Approval Pathway of Biosimilar Products
Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval fram...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2012-03-01
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| Series: | Pharmaceuticals |
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| Online Access: | http://www.mdpi.com/1424-8247/5/4/353/ |