FDA Approves First Biosimilar
By: Nigel Rulewski, MD | April 30, 2015
March 6, 2015 was a landmark day for the biosimilar manufacturers. It is the day that U.S. Food and Drug Administration (FDA) approved a biosimilar version of filgrastim, making it the first biosimilar product to enter the U.S. market.
The approval was no great surprise. An abbreviated licensure pathway for biosimilars approval in the U.S. was established in 2010 as part of the Affordable Care Act, and filgrastim offered an attractive package of attributes making it a prime candidate for FDA’s first step into this new product category. A biosimilar version of filgrastim has been on the European market for years, and the makers can provide hundreds of thousands of days of patient outcomes data, post approval, which provides FDA with deep assurances around its safety and efficacy.
I am optimistic that this will be the first of many biosimilars to complete this approval process as US regulators grow more comfortable with the reliability, quality and safety of biosimilar treatment options -- though admittedly, approval is only the first step.
Educating an industry
Newer biosimilars will face the significant challenge of driving uptake in a marketplace that is unfamiliar with the biosimilar benefits proposition. Studies show uptake of biosimilars in the EU has been variable, with success hinging on a number of factors including cost, competition, physician knowledge, payer support, pharmacy support, local market dynamics, marketing, and timing. The US marketplace is likely to face similar challenges.
There are many stakeholders involved in these decisions, and biosimilar manufacturers will effectively be tasked with building this marketplace from scratch. That means not only do they need to promote their new products, they will also be responsible for educating payers, physicians, patients, and pharmacies about what biosimilars are in general, and the unique quality, safety and efficacy attributes of their specific products. Achieving this buy-in and developing a baseline industry knowledge will be difficult, especially in the early days when biopharma companies will be marketing products to stakeholders who many have little or no knowledge about biosimilars.
A US path for biosimilar success
For manufacturers interested in bringing biosimilars to the US market, they should work closely with regulators early in the development process to be sure the product has the potential to be approved as a biosimilar. Similarly, they need to collect the appropriate data comparing their product to the innovators. In these conversations with regulatory agencies, researchers should be forthcoming about innovative new strategies that will show comparability in the phase III trial setting. Because these are early days for the biosimilars marketplace, the FDA is still open to new trial designs that will improve the efficiency and certainties around this process.
Then once the product is approved, biopharma companies need to devise marketing strategies that emphasize education around the quality, safety and efficacy of biosimilars in general. This will require more than just a good sales strategy. Physicians, payers and patients want real-world evidence and post-marketing data about biosimilars that demonstrates value, with no unintended consequences. Market research from the EU suggests that studies in relevant indications are often needed to promote physician adoption. However, whether insurers will dictate the use of biosimilars in an effort to contain costs remains to be seen.
While this first approval is an encouraging start, we are still at the very beginning of what will be an innovative and cost-saving process that has the potential to dramatically reduce health care costs.