Will 2017 Change the Fate of Biosimilars? An Update From the CBI Summit

Anna Rose Welch, editor of Biosimilar Development, describes a question raised at the 2017 CBI Biosimilars Summit in Alexandria, Virginia: Is 2017 going to be a “standstill” year for biosimilars? She reports that despite the many positive steps that have been taken to establish the biosimilar industry to date—including recent FDA guidance and several approvals—its success is still “looking hazy.”

Although small, the conference boasted an impressive array of speakers from a variety of stakeholders including physician and patient groups, payers, small biosimilar companies, and big Pharma, Welch said, and at every event she attended the focus was on the challenges facing the industry and concerns over regulations being established. The theme of the conference was strategic and tactical decisions for long-term success in the biosimilar market. Each presentation was structured as a discussion that aimed to get all attendees interacting with each other and the speaker.

Three themes ran through every session, Welch noted: risk, uncertainty, and frustration. In the biosimilar industry a number of external risks and uncertainty surround patient, physician, and payer response and adoption of biosimilars. Biosimilars are facing litigation and other defensive strategies mounted by originators, as well as market evolution. The United States, often a market leader, is following the rest of the world when it comes to biosimilars, Welch points out. Many unknowns remain with respect to future FDA regulations and the repeal of the Affordable Care Act (ACA). And there is frustration from biosimilar companies and payers that biosimilar uptake is going to be pushed by the payers. Formulary decisions made by CVS and UnitedHealth helped integrate biosimilars into treatments for new patients, but the actions of 2 payers is not necessarily going to be a rule for other payers who wish to wait and watch.

Some health insurers at the conference expressed disappointment in the small discounts offered by biosimilar makers, Welch reported. Small discounts mean that patients are unlikely to realize savings, giving smaller payers more reason to hesitate. Although the insurers understand that it will take time and more competition to drive sharper discounts, Welch explains that their experience with biosimilar pricing is colored by their experience with generic drugs, which offer much steeper discounts. There was too much optimism at the start that biosimilar prices would be lower right off the bat, which reflected a lack of knowledge of the complexity of biosimilars. Concerns over low biosimilar discounts can possibly be mitigated, but it will mean tremendous efforts must be made to communicate with and educate physicians and patients to “sell the biosimilar story,” perhaps dispelling patient concerns about biosimilar efficacy. Another issue to consider is that as reference drug makers negotiate with health insurers to renew contracts for the next year, payers may need to weigh whether savings for the patient can overcome the potential inconvenience of switching therapies.

Developments that are likely to affect the future of the biosimilar market in 2017 include the opportunity to pursue interchangeability. Welch notes that it isn’t likely that there will be an approval and marketing of an interchangeable biosimilar in 2017. There will be a Supreme Court ruling on the “patent dance” and timing of the 180-day notice of biosimilar marketing, however, and there will be a determination of what will happen to the ACA.

“The overarching message I took away from this conference was that it will be key in 2017 for companies to temper expectations and become familiar with uncertainty,” Welch concluded. The biosimilar industry will never have certainty, said summit chairman Edric Engert, senior vice president of biosimilars at Teva. Will 2017 turn out to be a “standstill year?” That depends on how the legal, development, and healthcare challenges play out. As Engert told conference attendees, 2017 may be an inflection point for companies. “We won’t so much be hitting a ‘pause’ button, but 2017 will be a time for many companies to slow down and consider just how involved they wish to be in the biosimilar market.”