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Policies & Legislation

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.

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.