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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.

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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.

API V13C22

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.

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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.

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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.

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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.

Pay for Delay V13C29

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.

Law V13C29

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.

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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’.

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Biosimilars bills move on in two US states

Home/Policies & Legislation | Posted 15/03/2013

The battle over biosimilar drugs is heating up in the US, with two states moving biosimilar bills along in the substitutability of biosimilars.

API V13C22

EU API law causing concern among API producers

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

Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.

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Tighter EU rules on pharmacovigilance for biologicals

Home/Policies & Legislation | Posted 06/04/2012

Last updated: 11 March 2013

The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists.

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MEPs adopt directive to give quicker access to generics

Home/Policies & Legislation | Posted 15/02/2013

Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.

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FDA gives details of generic drug user fees

Home/Policies & Legislation | Posted 01/02/2013

FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).

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India issues more compulsory licences

Home/Policies & Legislation | Posted 24/01/2013

The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the drugs before the patents expire on the originator drugs.

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India’s patent office at odds with Big Pharma

Home/Policies & Legislation | Posted 14/12/2012

India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Somewhat controversially the office has been asked by the Supreme Court, however, to reconsider Pfizer’s patent on Sutent (sunitinib). Meanwhile, it is still to issue a final verdict in Novartis’ legal challenge against India’s patent laws.

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Generic pre-emption raises its ugly head again

Home/Policies & Legislation | Posted 07/12/2012

The US Supreme Court is to review a case, which could determine whether generics companies can be held responsible for design flaws in the drugs they copy.

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FDA to tighten control over generics

Home/Policies & Legislation | Posted 23/11/2012

A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking more closely at the techniques generics drugmakers use to make extended-release drugs.

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Major shake-up of API import rules in Europe

Home/Policies & Legislation | Posted 23/11/2012

EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for human-use medicines. The new rules will come into force next year.

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Pharmaceutical trade barriers are falling

Home/Policies & Legislation | Posted 16/11/2012

The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce barriers to other Mediterranean neighbours and Canada.