Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
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What are Biosimilars?<br />
� Successor to a biological medicinal product for which patent protection<br />
no longer applies<br />
� Complex molecules manufactured by recombinant DNA technology<br />
(insertion <strong>of</strong> gene into the host cell to produce the protein)<br />
� Comparable with the reference product in terms <strong>of</strong> quality, efficacy and<br />
safety<br />
� Can be approved for the same indications for which the reference<br />
product is approved<br />
� Approved by EMA in a centralized procedure � as for innovators<br />
Biosimilars Biosimilars SEBs<br />
6 | Thomas Stangler | EAPB SIG Regulatory Aspects for Bio<strong>pharmaceutical</strong>s | October 4th, 2010 | Business use only<br />
Source:NGx<br />
Generic Biological<br />
Biogenerics
![Roy Forster [Kompatibilitätsmodus]](https://img.yumpu.com/7737040/1/190x135/roy-forster-kompatibilitatsmodus.jpg?quality=85)
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