Policies & Legislation

Further capping of generics in Japan

Home/Policies & Legislation | Posted 29/01/2016

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

Home/Policies & Legislation | Posted 15/01/2016

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

Home/Policies & Legislation | Posted 11/12/2015

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

Home/Policies & Legislation | Posted 04/12/2015

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

Home/Policies & Legislation | Posted 06/11/2015

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

Home/Policies & Legislation | Posted 23/10/2015

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

Home/Policies & Legislation | Posted 09/10/2015

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

Home/Policies & Legislation | Posted 02/10/2015

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

Home/Policies & Legislation | Posted 25/09/2015

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.

Concerns raised over CMS biosimilars reimbursement policy

Home/Policies & Legislation | Posted 19/09/2015

In July 2015, the Centers for Medicare & Medicaid Services (CMS), which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars. However, various groups have raised concerns about the proposal.

FDA issues warning letters to Indian firms

Home/Policies & Legislation | Posted 28/08/2015

The US Food and Drug Administration (FDA) is not letting up with its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Mylan and Mahendra Chemicals for good manufacturing practice (GMP) violations.

Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins

Home/Policies & Legislation | Posted 04/10/2013

Canada’s federal department responsible for health, Health Canada, is asking drugmakers seeking approval of similar drugs containing low molecular weight heparins (LMWHs) to use the approval pathway for subsequent entry biologics (SEBs), as they are called in Canada.