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Biosimilars and the role of regulatory authorities Biosimilars/Research | Posted 22/06/2018

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]:  (i)   manufacturing...

Celltrion resubmits biosimilar trastuzumab to FDA Biosimilars/News | Posted 22/06/2018

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food...

Developing biosimilars Reports | Posted 22/06/2018

Global pharmaceutical sales have grown 6.4% over the last five years to reach US$964 billion in 2017. Although the US still accounts for the major share of drug sales other markets are growing fast...

Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 Biosimilars/Research | Posted 22/06/2018

Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life...

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...