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Biosimilars Forum launched Biosimilars/General | Posted 08/05/2015

A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars in the form of the Biosimilars Forum.

Venezuelan approval for Celltrion’s Remsima Biosimilars/News | Posted 08/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Range...

The cost of specialty pharmaceuticals Reports | Posted 08/05/2015

Specialty pharmaceuticals, which include difficult-to-manufacture small-molecule chemical drugs and biologicals, account for approximately 25% of total prescription costs, with expenditures on spec...

FDA to hold public meeting on GDUFA Guidelines | Posted 08/05/2015

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of ne...

Pharmacist survey highlights increasing generics costs Reports | Posted 08/05/2015

A survey of pharmacists has once again highlighted the increasing cost of generics in the US.

Anticompetitive acquisition forces generics sale Pharma News | Posted 08/05/2015

US generics maker CorePharma has had to sell its rights of two generics in order to merge with fellow US drug company Impax Laboratories (Impax). The US Federal Trade Commission (FTC) ruled that Im...

FDA finalizes biosimilars guidelines Guidelines | Posted 04/05/2015

Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidanc...

Brazil approves first monoclonal antibody follow-on biological Biosimilars/News | Posted 04/05/2015

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biologica...