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US FDA Worried as California Passes Biosimilar Use Bill

By Dan Stanton+

28-Aug-2013
Last updated on 13-Sep-2013 at 16:52 GMT

As California approves a Bill constraining biosimilar substitution, the US FDA says it is concerned at efforts to undermine strict federal legislation already in place.

Senate Bill 598 , introduced earlier this year, was passed by the Californian Assembly 58-4 on Monday meaning physicians can refuse patients access to bioequivalents in favour of costlier patented drugs, and pharmacies will have to alert them when a biosimilar product is dispensed in place of a branded biopharmaceutical.

However, US Food and Drug Administration (FDA) spokesperson Lisa Kubaska told Biopharma-Reporter.com “efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower cost treatments.”

In 2010, Congress created approval pathway legislation on biosimilars which, according to Kubaskas, set a “very high bar for a biosimilar product approval,” requiring the manufacturer of the product’s to demonstrate biosimilarity, safety, and evidence of the product will produce the same clinical result as the reference product.

“The 2010 law expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”

Though Kubaska told us the FDA did not take any positions on specific State laws, she said “it is important for everyone to approach these issues with an understanding of both FDA's expertise in this area and what the 2010 law requires for approval of biosimilar and interchangeable products.”

Biosimilar Approval and Industry’s Response

The US is yet to have approved a biosimilar drug though Kubaska said the Center for Drug Evaluation and Research (CDER) “continues to meet with sponsors interested in developing biosimilar products” and, as of Monday, “had received 57 meeting requests for an initial meeting to discuss biosimilar development programs for 13 different reference products and held 47 initial meetings with sponsors.”

The passing of SB 598 is likely to be welcomed by drugmakers that have lobbied to protect sales of their patented biopharmaceuticals according to Dr. Howard Levine, President and Principal Consultant, BioProcess Technology Consultants.

He told this publication “the large biotech companies such as Amgen and Genentech are certainly doing all they can to protect their products so they clearly profit from any delay in biosimilar approvals in the US.”

Levine added that such BioPharma lobbying has taken place despite that fact that “many of them, including Amgen, are hedging their bets and now have biosimilar programs of their own.”

Spokesperson Robin Snyder of Genentech - which is not pursuing a biosimilars programme - said the firm is in favour of the Californian Bill “because it authorizes the dispensing of potentially less costly, FDA-approved biosimilar medicines while also ensuring patient and physician access to full and complete medical records.”

Amgen teamed up with Watson – now part of Actavis – in 2011 to develop biosimilars , though said at the time it will not pursue biosimilars of its own proprietary products.

In an official statement regarding the bill sent to Biopharma-Reporter.com the firm said "the laws pertaining to biosimilars must take into account those differences.

"As with all FDA-approved medicines, Amgen believes FDA-approved biosimilars will be safe. However, safety does not stop with approval.  States have an important role to play."

This article was updated on August 29 to include a statement from Amgen Biopharma-Reporter.com received after the article was first published.

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