January 30, 2013

Biotechnology Innovators Lobby Congress to Restrict Use of Biosimilars

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpgOn January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., "highly similar" versions of previously-approved, innovator biological products ("biologics"). According to the author, Andrew Pollack, Amgen and Genentech are proposing bills that would make it more difficult for pharmacists to substitute biosimilar versions for the innovator's products, unless FDA determines that a particular biosimilar version is "interchangeable" with the innovator's product.

For instance, the Virginia House of Delegates reportedly already passed such a bill last week by a 91-to-6 vote. Other bills in the works require patient consent for substitution, pharmacist notification of the patient's physician if a switch is made, and for both the pharmacist and patient's physician to maintain records of any such substitutions for years.

The Generic Pharmaceutical Association ("GPhA") and insurers generally accept that biosimilar substitution for a biologic should follow similar methods as with drugs only if deemed interchangeable by FDA but find that many of the bills go further to discourage use of biosimilars. "All of these things are put in there for a chilling effect on these biosimilars," commented Brynna M. Clark, Director of State Affairs for GPhA, adding that many of the limits "don't sound too onerous but undermine confidence in these drugs and are burdensome." GPhA and insurers would prefer that legislatures leave biosimilar regulation to FDA, which has been entrusted with using its regulatory prowess to determine the necessary requirements for biosimilars and "interchangeable" biosimilars, as well as when to waive those requirements based on what is know about a particular biosimilar product.

While it is not surprising that innovator biologics companies would want there to be restrictions on the use of biosimilars, or that the legislature would want to ensure the safety of the public health, these bills are being pursued even before there are biosimilar versions available or even in the application process at FDA. Yet as discussed in my recent chapter, "Challenges to the Development of a Biosimilars Industry in the United States", there are legitimate reasons exist why would-be biosimilar applicants have been reluctant to file their proposed biosimilar products until FDA has a track record. "These are really complex, highly-sensitive molecules," said State Senator Patricia Vance of Pennsylvania. "We want to make sure we are not hurting people," she added, while indicating that she plans to introduce a similar bill in her state.

Momenta Pharmaceuticals, which describes itself as a company developing biosimilars, told the The New York Times, "We're still dealing with chaos. This is a pathway that neither industry nor the FDA knows how to use." Indeed, the new biosimilars pathway is at a minimum already two and half years old, from its passage in the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), but conceptually has been discussed much longer.

From reports, it appears that state legislatures have started with this approach largely because the biotechnology innovators were first to speak to legislature about their concerns. Amgen reportedly provided $22,000 to Virginia state legislatures in both 2011 and 2012, double the $11,000 provided in 2010. Dr. John O'Bannon III, the Republican delegate who introduced the Virginia bill that passed last week, noted that he introduced the bill because he was familiar with biologics as a practicing neurologist, plus "The Amgen folks actually did come and talk to me."

So, if GPhA and the would-be biosimilar industry is paying attention, the lesson learned would be that it is never to early to begin speaking with your Congressman, even if your biosimilar product is still in its infancy, and to start speaking with FDA to determine the necessary requirements to enter the race. With such big players and money at stake, the race will only begin with FDA and continue into the courtrooms with patent infringement litigations that are likely to continue for as long as and perhaps longer than it will take FDA to determine the correct pathway for approval of the first biosimilars.