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Policies & Legislation

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.

Concerns raised over CMS biosimilars reimbursement policy

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

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

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.

FDA issues more warnings to Indian firms

The FDA is keeping up its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Posh Chemicals and Promed Exports for good manufacturing practice (GMP) violations.

FAST generics act re-introduced to increase generics competition

On 18 June 2015, US lawmakers Steve Stivers and Peter Welch re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generics, boost market competition and ultimately save consumers money.

EU stands by call for Ireland to reduce drug prices

The European Commission (EC) is standing by its call for Ireland to reduce spending on medicines in the country, despite objections from originator companies.

WHO issues draft proposal for its biological qualifier

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. Now the body has issued a draft proposal covering the issue of how to name biologicals, including biosimilars.