The Generic Pharmaceutical Association (GPhA) last week reiterated its commitment to safeguarding the intent of the Biologics Price Competition and Innovation Act (BPCIA) and ensuring that patients have timely access to safe, effective and affordable biosimilar medications.
“GPhA’s priority is to support safe, pure and potent biologics being made available to all patients who need them with no compromise in quality,” said Ahaviah Glaser, GPhA Vice President for Policy and Strategic Alliances, in comments to the FDA public meeting. “Moving forward, we will work to ensure that no barriers, like unique non-proprietary names or unnecessary clinical trials, are put in place that could raise safety concerns or interfere with the competitive market BPCIA was designed to create.”
GPhA has long maintained that, as proven with chemical prescription drugs, competition from generics will be the most important factor in holding down the cost of biologic medicines. In comments submitted in response to the FDA’s draft guidance on biosimilars, the Association stressed several key issues, including:
- What matters most to patients is that all biologics licensed by the FDA — reference product or biosimilar — are approved to the same standards. If these uniform standards are applied, providers and patients alike can trust FDA’s approval of biosimilars as safe, pure and potent.
- A determination of interchangeability is essential to creating a robust, competitive market for biosimilars. This should be science-based for biosimilars, just as for reference products, and available as part of the initial approval process.
- All biosimilars should be tracked uniquely, but this does not require, and in fact would be inhibited by, a unique International Nonproprietary Name (INN).
“As we all know, biologic drugs have revolutionized modern medicine, providing vital treatments for patients with a wide range of conditions,” Glaser said. “With the application of the best-in-class scientific standards and most appropriate methodologies — while avoiding the creation of artificial barriers to market entry — the FDA will make the BPCIA a success.”
Source: GPhA press release