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Sandoz starts phase III US trial for biosimilar epoetin alfa Biosimilars/Research | Posted 09/11/2012

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 25 October 2012 that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alf...

The latest biosimilars agreements Biosimilars/News | Posted 09/11/2012

Biosimilar is still the hottest subject around.  Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and B...

Japanese firms developing biosimilars Biosimilars/News | Posted 09/11/2012

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Moc...

Health Canada publishes draft GMP guideline for APIs Guidelines | Posted 09/11/2012

Health Canada announced on 22 October 2012 the publication of a draft guideline on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs).

India patent laws under close scrutiny Policies & Legislation | Posted 09/11/2012

The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).

FDA ordered to let Watson sell generic Actos Generics/News | Posted 09/11/2012

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered...

Biosimilar terminology confusion Biosimilars/Research | Posted 26/10/2012

Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA [1].

Momenta versus Amphastar and the safe harbour provision Generics/General | Posted 26/10/2012

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reas...