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Policies & Legislation

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.

Biosimilars substitution bill becomes law in California

California is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, 14 states have passed legislation requiring prescriber communication and record keeping for biosimilars [1, 2].

How will biosimilars be affected by the TPP

Since 2009, the US Government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions. This agreement could have major impact on the pharmaceutical market, including generics and biosimilars.

Pay-for-delay bill reintroduced

On 9 September 2015, in an effort to stop pay-for-delay deals in the pharmaceutical industry, two US senators reintroduced the Preserve Access to Affordable Generics Act.

Pfizer loses UK patent protection for Lyrica in pain

Pharma giant Pfizer suffered a major blow in the UK on 10 September 2015 when the High Court in London ruled that claims of patent protection for the use of its blockbuster drug Lyrica (pregabalin) as a pain treatment were invalid.