US Just Scratching Surface of Biosimilar Landscape

Now that the first biosimilar—filgrastim-sndz—has entered the US marketplace, policies and perceptions around these complex medicines are unfurling. With more biosimilars expected to enter the marketplace in the coming years, lingering questions around the future of biosimilars poses challenges for stakeholders.

“We are going into an area that is unprecedented in the US marketplace and there are many unknowns,” said Michael E. Castagna, PharmD, vice president, global biosimilars commercial lead, Amgen, during the “The Biosimilar Frenzy: Facts, Fiction, and Future” webinar presented by Amgen and hosted by America’s Health Insurance Plans.

Unknowns that can have an impact on the success or failure of a biosimilar market include extrapolation, naming, interchangeability, physician and patient acceptance, track and traceability, and coverage and reimbursement, according to Dr Castagna.

“I think we are all focused on the tip of the iceberg. The reality of how we get there is still below the surface,” he said.

One important area for stakeholders is the process for interchangeability. Dr Castagna explained that a biosimilar should only be considered interchangeable with the reference product if the FDA has approved it as a biosimilar and designated it as interchangeable once additional criteria have been met. Dr Castagna said he expects the criteria and other questions on what is needed for interchangeability to be answered in future draft guidance from the FDA. 

“Interchangeability will be a higher hurdle for any biosimilar coming to market and will likely require additional clinical investment beyond the initial filing,” he said.

Potential cost savings is important for stakeholders, Dr Castagna said. “Driving down costs of biologics is an ongoing initiative across the health care market. Biosimilar cost savings projected vary and will probably be in the 20% to 30% range depending the competition,” he said, noting that cost savings could be higher but will depend on how savings is calculated. According to a 2014 RAND Corporation analysis, biosimilars are expected to reduce direct spending on biologics by $44.2 billion over the next decade in the United States.

Patient and physician acceptance of biosimilars is a potential barrier. For example, some physicians are not going to prescribe biosimilars especially in competitive markets where multiple therapeutic choices are available such as rheumatoid arthritis. “Physician and patient acceptance are important for market uptake in the United States,” Dr Castagna said.

Important considerations for a biosimilar manufacturer include a system to reliably supply their products and robust anticounterfeiting measures. “I predict that private payers are going to be the ones to have to set the tone and be leaders around adoption of biosimilars in the next couple of years,” he said. 

Investment in support services is also important and will vary among biosimilar manufacturers. Factors manufacturers need to consider include the ability to provide broad education across stakeholders and resources to address needs. “We continue to see the challenges of lack of awareness around biosimilars,” he said. “It is going to take a substantial amount of investment from the government as well as the private industry to educate and inform the marketplace around what are biosimilars and how are they characterized.”

“This market will continue to evolve. It’s getting more competitive by the day,” Dr Castagna concluded. “It’s an exciting time be at the infancy of a new market here in the United States. When you look at where the marketplace is evolving, its gone from pure generic companies doing these [biosimilars] to large multinational pharmaceutical companies having a biosimilar arm.”—Eileen Koutnik-Fotopoulos