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EU problematic patent settlements stabilize Reports | Posted 09/01/2015

The number of patent settlements between originator and generics companies concluded during 2013 has reduced compared to 2012. While the number of problematic or so-called ‘pay-for-delay’ deals hav...

First infliximab ‘similar biologic’ launched in India Biosimilars/News | Posted 09/01/2015

India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be...

GPhA comments on generics’ legislation and Trans-Pacific Partnership Generics/General | Posted 09/01/2015

Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific P...

Phase I study shows darbepoetin alfa biosimilar to be well tolerated Biosimilars/Research | Posted 09/01/2015

Chong Kun Dang Pharmaceutical (CKD Pharma) announced on 18 November 2014 the successful completion of its phase I pharmacokinetics study for its biosimilar darbepoetin alfa product.

Generics makers to be penalized for huge price hikes Policies & Legislation | Posted 09/01/2015

Legislation was introduced into the US Senate on 20 November 2014 that, if passed, would require generics makers that increase prices dramatically to pay a rebate to Medicaid*.

Biosimilars could save US$44.2 billion over 10 years Reports | Posted 09/01/2015

Introducing biosimilars of complex biologicals used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologicals in the US by US$44 billion over the next decade, acc...

Extrapolation of indications in biosimilars: epoetin Biosimilars/Research | Posted 12/12/2014

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially in extrapolated* indications. Members of the European Medicines Agency's...

Canada’s generics are too expensive Generics/Research | Posted 12/12/2014

The same generics cost more in Canada than they do in similarly developed countries. In response to this, the premiers of each Canadian province recently agreed to lower the price of six expensive...