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Policies & Legislation

New bill would stop brand-name pharma restricting drug samples

A new Senate bill would stop brand-name drugmakers from blocking generics competition by closing regulatory loopholes preventing generics makers from obtaining samples of the reference materials needed to test candidate generics and biosimilars.

GPhA raises concerns over CMS biosimilars reimbursement policy

The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council have raised concerns that the Centers for Medicare & Medicaid Services (CMS) proposed demonstration to revamp how Part B pays for prescription drugs will ‘erode the economic incentives that drive the US healthcare system to lower-cost therapeutic alternatives’, especially for biosimilars.

The Netherlands to track switching of biologicals

In response to an expected increase in the use of biosimilars in the country, The Netherlands Minister of Health, Edith Schippers, announced on 19 May 2016 the set-up of a national system to monitor the safety of biologicals.

Colombia fighting to break Glivec monopoly

Colombia has appealed to the World Health Organization (WHO) in an attempt to break the monopoly Swiss pharma giant Novartis has for its blockbuster cancer drug Glivec (imatinib) in the country.

China introduces new quality and efficacy requirements for generics

The Chinese Food and Drug Administration (CFDA) has announced that generics in China must show bioequivalence to the originator reference product and has prohibited the use of locally made generics as reference products.

Industry calls for generics user fees to be reduced

Generics makers and industry groups have commented on the Generic Drug User Fee Amendments (GDUFA) reauthorization, calling for lower user fees and greater transparency in the review process.

US state legislation on biosimilars substitution

Despite the fact that the US Food and Drug Administration (FDA) has yet to receive a biosimilars application, many US states have been considering legislation on biosimilars substitution [1].

California Assembly passes biosimilars substitution bill

California has taken a step closer to adopting legislation which would authorize pharmacists to substitute an FDA-approved biosimilars for their reference biologicals with a notification to prescriber within five days.

California governor vetoes biosimilars bill

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.

Colombia recommends compulsory licence for Glivec

A committee of the Colombian Ministry of Health and Social Protection has recommended a compulsory licence to be issued for cancer treatment Glivec (imatinib) sold by Novartis.