Reps. Henry A. Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson are giving another try at getting a pathway set for follow-on biologics.  They have introduced H.R. 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act,” a bipartisan bill to allow the Food and Drug Administration to approve generic copies of biotech drugs.  The bill is similar to H.R. 1038, the Access to Life-Saving Medicine Act, that was introduced last year and failed.

Unlike traditional chemical drug approval, the Food and Drug Administration currently has no process for approving biogenerics, also called “follow-on biologics” and “biosimilars.” Generally, biotech drugs are more complicated than regular drugs because they are made from living cells or bacteria.

For a generic drug manufacturer to win approval of a generic version of a traditional prescription drug, the product must have the same active ingredient, strength, dosage form and route of administration as the original drug. This means that generic drugs are the exact same chemically as their brand name counterparts and they act the same way in the body.

According to a press release:

“While biologics are highly effective medications in the treatment of a host of debilitating and life-threatening medical conditions, biologic drugs often cost on average 22 times more per daily dose than chemical medications, the most expensive of which costs well over $100,000 per year,” said Rep. Deal. “It is expected approximately 50% of all drugs approved in 2010 will be a biopharmaceutical.”

Highlights of H.R. 1427:

FDA authority.  The bill authorizes the Food and Drug Administration to approve abbreviated applications for “biosimilar” and “biogeneric” (interchangeable) biological products.

Approval of “biosimilars.”  An application for a biosimilar version of a biological drug must demonstrate to FDA that there are no clinically meaningful differences between the two products.  The application must also show that the two products are highly similar in molecular structure and share the same mechanism(s) of action, if known.

Approval of “biogeneric” or “interchangeable” products.  An applicant for a biosimilar may also try to establish that the product is “biogeneric,” i.e., “interchangeable” with the original product.  A product found by FDA to be interchangeable can be safely substituted for the original product, if state law permits.  The bill grants 6 months of exclusive marketing to the first applicant to demonstrate interchangeability to FDA.

Clinical studies.  The FDA has full scientific discretion to determine what studies are necessary to establish that (a) a biosimilar is as safe and effective as the original product, and (b) a biogeneric is interchangeable with the original product.  FDA can require the applicant to conduct clinical studies in both instances.

Modified products.  An applicant may submit an abbreviated application for a product that differs from, or incorporates a change to, the original product, if the application contains sufficient information to show that the new product is safe, pure, and potent (safe and effective).

Post-market studies.  The FDA has full discretion to require post-market safety studies for biosimilars and biogenerics.

User fees.  A company that files an application for a biosimilar biological product must pay a user fee to FDA just as companies for innovative products do.

Initial exclusivity.  Consistent with Hatch-Waxman exclusivity periods, an original product with a novel molecular structure is entitled to only 5 years of exclusive marketing.  A modification of a previously approved product is entitled to just 3 years of exclusive marketing in some instances.

Exclusivity Extensions.  These periods can be extended by up to 1 year if the applicant establishes that the product can be used for a new disease indication or conducts pediatric studies.

Patent Disputes.  The bill establishes a procedure for resolution of patent disputes before a biosimilar is approved, and establishes penalties for failure to litigate patents in a timely fashion.

See reactions:

GPhA Statement on the Introduction of the Bipartisan Biogenerics Consensus Bill:

As our nation acts to strengthen our health care system, our priority must be to reduce costs while increasing access to quality care. Studies continue to show that creating a workable biogenerics approval pathway will not only bring life-saving medicines to patients in need, it will also save our health care system billions of dollars.

Biotechnology Industry Organization (BIO):  New Proposed Biosimilars Pathway Filled With Potholes:

The Biotechnology Industry Organization (BIO) continues to support strongly the development of a pathway for the review and approval of biosimilars.  Unfortunately, the legislation introduced today would take patients and our industry down the wrong path – a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer’s.   This legislation sets a path that jeopardizes our ability to help meet President Obama’s call for a cure to cancer ‘within our time’ and help realize the promise of stem cell research.

This bill seeks to cut prices but instead cuts corners.  This proposal leads us off the map as we seek an effective, fair and safe pathway to a biosimilars market.

The legislation introduced today does not strike the necessary balance for patients or the economy.   Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars.

The bill has been endorsed by, among others, the Consumers Union, AARP, the National Organization of Rare Disorders, the Coalition for a Competitive Pharmaceutical Market, General Motors, Express Scripts, Inc, the National Business Group on Health, the AFL-CIO, and the SEIU.

Sens. Schumer, Collins, Brown, and Vitter are expected to introduce a bipartisan companion bill in the Senate in the near future.

More here:  Rep. Waxman Introduces Follow-On Biologics Bill; Legislation Hews Closely to Hatch-Waxman Exclusivity Paradigm

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