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Oncobiologics and Viropro make biosimilar deal Biosimilars/News | Posted 01/03/2013

US-based Oncobiologics and monoclonal antibody developer Viropro announced on 25 February 2013 that they had signed a biosimilar collaboration agreement between the two companies.

Biologicals in EU to be identified by brand names Policies & Legislation | Posted 22/02/2013

The European Commission has issued a directive, which requires biological products to be identified by brand name and not by international nonproprietary name (INN).

Assessment of interchangeability under the BPCI Act Biosimilars/Research | Posted 22/02/2013

The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be subs...

Amgen’s response to biosimilar substitution legislation in US Biosimilars/News | Posted 22/02/2013

Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrai...

The ethics of biosimilars Biosimilars/Research | Posted 22/02/2013

Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical l...

Drug shortages linked to quality control costs Pharma News | Posted 22/02/2013

Lack of reward for manufacturing quality is forcing manufacturers of sterile injectable generics to reduce investments into quality system and is leading to drug shortages, according to FDA officia...

Merck makes biosimilars deal with Samsung Bioepis Biosimilars/News | Posted 22/02/2013

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.

Pfizer asks US Court to reconsider generic Reglan ruling Generics/News | Posted 22/02/2013

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.