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Policies & Legislation

Oregon passes biosimilars substitution law

Oregon is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 16 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Kentucky Senate passes biosimilars substitution bill

The Kentucky Senate is the latest US state to pass a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

UK’s competition authority fines GSK for pay-for-delay

The UK’s Competition and Markets Authority (CMA) announced on 12 February 2016 that it had fined GlaxoSmithKline (GSK) GBP 37.6 million for anticompetitive conduct and agreements in relation to the supply of paroxetine.

Obama budget aims to increase use of generics and biosimilars

President Obama has revealed plans to increase the use of generics and biosimilars in his fiscal year 2017 budget proposal.

Biosimilars in UK gain NICE recommendation

Biosimilars may be set to increase their market share in the UK after the country’s healthcare cost watchdog recommended that rheumatoid arthritis patients indicated for treatment with biologicals should ‘start treatment with the least expensive drug’.

Further capping of generics in Japan

In a bid to increase uptake of more cost-effective drugs and to curb healthcare spending, the Japanese Government has put forward plans to price generics at half the cost of brand-name drugs from April 2016, a reduction of 10%.

Michigan introduces new biosimilars substitution bill

Michigan is the latest US state to introduce a bill that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-4].

Further problems for Indian manufacturing sites

The US Food and Drug Administration (FDA) has written to Sandoz after identifying significant violations of current good manufacturing practice (cGMP) at two of the company’s manufacturing sites in western India, Turbhe and Kalwa. Turbhe is an Active Pharmaceutical Ingredient and Finished Dosage Manufacturing Site, Kalwha is a Finished Dosage Manufacturing Site.

New Jersey passes biosimilars substitution bill

New Jersey is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 15 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1-3].

Senator calls for FTC to investigate drugmakers for antitrust violations

In light of recent drug price increases a US Senator has called on the US Federal Trade Commission (FTC) to investigate pharmaceutical companies for possible antitrust violations.