Policies & Legislation

Generics makers to self-identify for FY2014 generics fees

Home/Policies & Legislation | Posted 10/05/2013

FDA has informed generics and active pharmaceutical ingredient (API) manufacturers that they will have one month to self-identify for the generics drug user fees for fiscal year (FY) 2014.

EMA publishes concept paper on extrapolation

Home/Policies & Legislation | Posted 03/05/2013

EMA published a concept paper on extrapolation of efficacy and safety in drug development in April 2013. The publication of the concept paper comes at a time when extrapolation for biosimilars is a hot topic.

China and India still to comply with new EU API rules

Home/Policies & Legislation | Posted 29/04/2013

The European Union (EU) has introduced new rules for importing active pharmaceutical ingredients (APIs) for human use into Europe; however, two of its biggest suppliers have yet to put systems in place to comply with these new rules.

Indian high court allows sitagliptin generics

Home/Policies & Legislation | Posted 19/04/2013

In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus allowing generics to remain on the Indian market.

Indian Supreme Court rejects Glivec patent

Home/Policies & Legislation | Posted 12/04/2013

On 2 April 2013, the Supreme Court of India rejected drugmaker Novartis’ seven-year battle to patent its cancer drug Glivec (imatinib mesylate), ruling that the drug was not a new invention.

US FTC sides with generics makers over drug samples

Home/Policies & Legislation | Posted 05/04/2013

The US Federal Trade Commission (FTC) has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions.

Brand-name drug and generics makers fight to save pay-for-delay

Home/Policies & Legislation | Posted 29/03/2013

Brand-name drug and generics manufacturers are joining forces to fight against the US Federal Trade Commission (FTC) in the case of reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.

US state biosimilar substitution bill becomes law

Home/Policies & Legislation | Posted 29/03/2013

On 21 March 2013, the US State of Virginia signed into law a legislation allowing for the substitution of biosimilars, but with many restrictions, making it the first US state to introduce such legislation. Brand-name biologicals manufacturers have praised the law as putting patients first, but the generics industry has accused it of pre-empting FDA guidance.

Evergreening patents may make drugs too costly for patients in Thailand

Home/Policies & Legislation | Posted 22/03/2013

Many medicines will become too expensive for patients in Thailand in the near future if the government allows manufacturers to extend patents under the so-called ‘evergreen system’.