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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...

MSF launches online ‘Patent Opposition Database’ Policies & Legislation | Posted 26/10/2012

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developin...

Future biosimilar targets Reports | Posted 26/10/2012

It seems biological medicines are set to play a major part in the pharmaceutical industry’s future and they already play a major part in its current growth [1]. At the moment, biologicals account f...

Glossary of key terms Biosimilars/General | Posted 26/10/2012

Last update: 13 February 2015Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to...

Reliance Life Sciences starts ‘similar’ infliximab trial in India Biosimilars/News | Posted 26/10/2012

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity Generics/News | Posted 26/10/2012

US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the...

STC Biologics receives US$2.5 million for biosimilar mAb development Biosimilars/News | Posted 26/10/2012

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Can...