Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R- TX) have introduced the Pathway for Biosimilars Act (H.R. 1548). The key provision of the Eshoo-Inslee-Barton bill is the 14-year data protection period. It would offer all new biological drugs a base period of 12 years of data protection with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.
The California Healthcare Institute (CHI) President and Chief Executive Officer David Gollaher, Ph.D., issued his support for the bill:
While focused on the development of the next generation of innovative medicines, we understand that the increasing cost of healthcare is a growing burden for private-sector and government budgets. In the long term, competition among biosimilar products is likely to yield savings within the U.S. healthcare system. Considering the complexity of large molecule product development and manufacturing, CHI believes that it is possible to develop a successful, science-based FOBs approval pathway. This pathway must employ the best science to ensure the safety of products for patients, encourage price competition among manufacturers, and provide ample incentives to encourage continued private-sector investment in the next generation of breakthroughs.
The CHI contends that the Pathway for Biosimilars Act’ meets these standards:
1. Clear Guidance: As suggested by the FDA’s Chief Scientist in his recent letter to Congress, this legislation requires the FDA to formulate scientific standards for FOBs approval and determination of interchangeability through a flexible, clear, and public guidance process;
2. Clinical Trials and Safety: Ensures that no follow-on product is approved without appropriate and careful scientific demonstration, including the assessment of immunogenicity, that the product is ‘biosimilar’ to the approved reference biological product;
3. Patent Dispute Resolution: Establishes an equitable framework for exchanging information among innovator manufacturers, biosimilar manufacturers and third-party patent holders, such as universities and private research institutes whose scientific breakthroughs are licensed to the private sector for commercial development.
4. Innovation: Encourages future investment in biopharmaceutical research and development by providing at least 12 years of data exclusivity before the FDA can reference the expensive and time-consuming safety and efficacy testing conducted by an innovator in order to approve a follow-on product. This critical element both recognizes that follow-on manufacturers, developing products that are ‘similar’ to innovators’ products, may work around innovators’ patents. The protection of clinical trials data is thus far more important for biologics than for traditional chemical pharmaceuticals; we believe that 12 years of protection will produce outcomes for biotechnology companies similar to those currently in place for traditional pharmaceuticals under the Hatch-Waxman bill of 1984.
The Biotechnology Industry Organization (BIO) president Jim Greenwood said the bill strikes the right balance between innovation and balance. The industry group is against the earlier bill introduced by Rep. Henry Waxman, that would give brand-name biologics just five years of exclusivity, saying it would undercut innovation. The Eshoo-Barton-Inslee bill “provides patients with the right balance between innovation and competition,” said Greenwood in a statement.
Needless to say, the Generic Pharmaceutical Association (GPhA) released its statement from GPhA President and CEO Kathleen Jaeger opposing the introduction of the Pathway for Biosimilars Act:
Unfortunately, The Pathway for Biosimilars Act is the wrong medicine for patients and our nation’s health care system. This bill will only benefit brand companies by erecting barriers including an unprecedented and unjustifiable 14 years of market exclusivity. Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines.
Follow the progress of the Pathway for Biosimilars Act here.
