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Brand-name drugmakers gain extra days of patent protection Generics/General | Posted 23/10/2015

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that dru...

Insulin glargine biosimilar in US delayed until end 2016 Biosimilars/News | Posted 23/10/2015

Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue si...

ADHD generic receives US FDA approval Generics/News | Posted 23/10/2015

US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.

Australia’s DoH seeks feedback on biosimilars awareness project Biosimilars/General | Posted 16/10/2015

Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do thi...

Pharmacovigilance compliance for biocomparables in Mexico Biosimilars/Research | Posted 16/10/2015

Filgrastim is widely used in Mexico, as in other countries. Its patent has expired and hence several non-originator biologicals have appeared. Following WHO guidelines, the General Health Law of Me...

FDA to hold public meeting on reauthorization of BsUFA Guidelines | Posted 16/10/2015

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Biosimilar User Fee Act (BsUFA) performance goals ahead of negotiations to reauthorize the law.

Effectiveness and cost-effectiveness of osteoporosis drugs Generics/Research | Posted 16/10/2015

Comparison of treatments for osteoporosis has shown that pharmacological intervention for prevention of secondary fractures is cost-effective [1].

Positive phase I results for pegfilgrastim biosimilar Biosimilars/Research | Posted 16/10/2015

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 1 October 2015 that results from a phase I study of its pegfilgrastim biosimilar (CHS‑1701) had met its primary endpoint.