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FDA publishes list of companies that block generics Generics/General | Posted 22/06/2018

The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.

Strides and Apotex to merge Australian generics businesses Pharma News | Posted 22/06/2018

India-based generics manufacturer Strides Shasun (Strides) announced on 9 May 2018 that it had made an agreement with Canada-based Apotex to merge their Australian businesses.

US approval for prostate cancer formulation and impotence generics Generics/News | Posted 22/06/2018

The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.

Spanish associations sign biosimilars collaboration Biosimilars/General | Posted 22/06/2018

The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agr...

Life cycle and regulatory evaluation of biosimilars Biosimilars/Research | Posted 15/06/2018

The life cycle of a biosimilar, like any biological, starts with research and development, then manufacturing, and is followed by regulatory evaluation of quality, safety and efficacy for both lice...

Update on the biosimilar programme in the US Reports | Posted 15/06/2018

A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Etanercept biosimilars submitted to EMA and launched in Japan Biosimilars/News | Posted 15/06/2018

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.

EC proposes waiver of SPCs to allow manufacturing of generics and biosimilars Policies & Legislation | Posted 15/06/2018

The European Commission (EC) announced on 28 May 2018 a proposal to refine the intellectual property rules in Europe and thereby remove a major competitive disadvantage for European Union (EU) manu...