Senate Committee Passes Biologics Legislation

    By Donald Zuhn --

Last week, the U.S. Senate Committee on Health, Education, Labor & Pensions announced that it had passed the Biologics Price Competition and Innovation Act.  According to a Committee press release, the bill (S. 1695) "includes standards for the FDA to approve follow-on biologics, a procedure designed to help resolve patents in an expedited way, and strong but responsible incentives to encourage innovation and the development of new therapies."

The bill was referred to committee on May 25, 2007 after being introduced by Senators Judd Gregg (R - NH), Richard Burr (R - NC), and Tom Coburn (R - OK).  The bill is being sponsored by sponsored by Committee Chairman Edward Kennedy (D - MA) and Senators Orrin Hatch (R - UT), Hillary Clinton (D - NY), Mike Enzi (R - WY) and Charles Schumer (D - NY).

Senator Kennedy stated that the bill "reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public."  Senator Hatch thought the Committee had "achieved a good balance" by giving incentives to continue biological development while allowing generic companies "to do what they do best - bring low-cost versions to the market," and ensuring that "patients and providers not only have access to low-cost biologics but that they're also safe."  Senator Enzi noted that because biologics "can't easily be duplicated, and the slightest differences can be fatal," it was imperative that the bill ensure that approved biologic therapies would be safe and affordable.

According to the Committee's statement, the Biologics Price Competition and Innovation Act would amend § 351 of the Public Health Service Act to provide for an approval pathway for biosimilars (interchangeable biological products), relying in part on the prior approval of the corresponding brand product.  A biosimilar applicant would be required to demonstrate (using analytical data, animal testing, and one or more clinical studies) that there are no clinically meaningful differences in safety, purity, and potency between the biosimilar and the brand product.  Under the Act, the FDA would be permitted to waive such a demonstration as unnecessary.

The Act provides incentives for the development of new biological products and interchangeable biosimilar products.  In particular, the Act affords entities that develop new biological products with 12 years of data exclusivity during which a biosimilar may not be approved, and affords entities developing the first biosimilar of a biological product with 1 year of exclusivity.

The Act also includes a multi-step process for identifying and resolving patents that a biosimilar may infringe.  The biosimilar applicant is first required to provide information regarding the biosimilar and manufacturing process to the brand company.  Next, both the brand company and biosimilar applicant identify any patents in question and are allowed to opine on the issues of validity or infringement.  Once the brand company and biosimilar applicant have agreed to a list of patents to be litigated (or have exchanged a list of patents when no agreement can be reached), the brand company is given 30 days to file suit against the biosimilar applicant for infringement.

If a brand company fails to identify a patent for litigation, the Act prevents the brand company from ever asserting that patent against the biosimilar applicant.  If the brand company decides not to litigate an identified patent, the Act requires a biosmilar applicant to give the brand company notice 180 days before launching its product, and limits the brand company's damages to a reasonable royalty if the brand company subsequently decides to litigate the patent.  Under the Act, if a brand company receives a judgment of validity and infringement before the 12-year data exclusivity period has run, the biosimilar applicant will be enjoined from infringing the patent until it expires.

Comments

[Manish Garg]

If this bill has been passed, can we have the guidance document for therse follow on biologicals?

[Donald Zuhn]

Manish:

While the Senate has passed its version of the biologics bill, the House has not passed its own version, and therefore, no biologics legislation has been signed into law at this time. It is my understanding that Congress will put the biologics legislation back on the table in 2008. We will continue to report on this issue as it develops.

Don