Stakeholders Stress Need for Reliable Information, Streamlined Evidence Requirements

Negative information about biosimilars continues to hold back the market for these drugs in the United States, and the FDA and Federal Trade Commission (FTC) need to take steps to educate providers and the public with “scientifically accurate” data, stakeholders told members of the FDA and FTC at a high-profile workshop Monday in Washington, DC.

Physicians and biopharmaceutical representatives expressed their opinions at a kickoff meeting designed to spur collaborative efforts to suppress anticompetitive practices in the US biosimilars market and pearl-dive for ideas to spur adoption of biologics that lower prices for patients.

Calls were also heard for efforts to promote smooth switching of biosimilars for innovator brands at the pharmacy counter and to eliminate superfluous requirements for evidence to demonstrate biosimilarity and interchangeability, while keeping patient welfare and safety topmost in mind.

“We are very concerned that there has been and continues to be a pattern of negative information about biosimilars to patents, healthcare professionals and others who have a role in the adoption of biosimilars in the United States,” said Juliana “Julie” Reed, MS, vice president and corporate affairs lead, Global Inflammation & Immunology and Biosimilars at Pfizer, and president of the Biosimilars Forum, a consortium representing the interests of biosimilars developers.

“The members of the forum have spent hundreds of millions of dollars to bring biosimilars to the market…. We all know the market is not working and it is not working for the patients we are here to serve,” she said. “We need Congress, CMS, payers, patients, and others to start to proactively support the uptake of biosimilars in this country.”

Improving provider education about biosimilars is a significant component of the FDA-FTC collaboration. Philip J. Schneider, MS, international advisory board chair for the Alliance for Safe Biologic Medicines (ASBM), stated there is a misperception that physicians in the United States lack confidence in biosimilars—“namely that biosimilar uptake in the United States is strongly linked to low physician confidence and that physician confidence has been depressed because of anticompetitive practices.”

Schneider remarked that exposure to biosimilars in Western Europe has contributed to high physician confidence there. “European physicians have had 13 years of experience with biosimilars and, depending on the country, between 82% and 93% of prescribers consider themselves very familiar with biosimilars; between 80% and 99% will feel comfortable prescribing a biosimilar to a new treatment patient,” Schneider said, citing a 2019 ASBM study of physicians in France, Germany, Italy, Spain, Switzerland, and the United Kingdom. “Between 46% and 76% would be comfortable switching a patient from a reference product to a biosimilar even if they were stable on the current medicine.”

In the United States, rheumatologists, at least, appear to be highly confident in approved biosimilars, said Madelaine A. Feldman, MD, a rheumatologist and chair of ASBM. In a poll conducted at a recent national meeting of rheumatologists, all responded that they thought biosimilars were not inferior to originator drugs, and none said they would have any hesitancy prescribing biosimilars, she said.

“There appears to be, at least, no negative feelings in that regard. But I have to admit, [rheumatologists] are generally more cautious and conservative regarding the treatments and are hesitant to change, particularly when it comes to changing a stable patient. It can take years to stabilize a patient with rheumatoid arthritis, and rheumatologists have been sensitized to nonmedical switching by payers,” Feldman said.

Sundar Ramanan, PhD, MBA, vice president and head of Global Regulatory Affairs for Biocon, called upon the FDA to shorten the review time for insulin products once applications for their approval have been filed, in light of the “high financial unmet need.” The agency already has set precedent for this in the generic space, he said.

Ramanan also asked the agency to reconsider the need for multiple switching studies for interchangeability, given the “abundance of real-world evidence and frequent marketplace switching,” as well as the need for “any distinction between the evidence requirements for biosimilarity and interchangeable biologics. Any regulatory requirement must be based on science and evidence and not based on fear.”

The immunogenicity data requirements for biosimilars already satisfy the data requirements for interchangeability, he contended.

Laura Brand, MBA, biosimilars global commercial lead for Amgen, stated that “current regulatory and reimbursement policies for biosimilars are working to promote competition.” Amgen has 10 biosimilars in development, including 4 approved by the FDA. The company’s innovator products have faced biosimilar competition since 2015. Amgen brands that are competing with biosimilars include Neupogen (filgrastim), Neulasta (pegfilgrastim), and Epogen (epoetin alfa).

“In 2019, Amgen launched the first therapeutic oncology biosimilars in the United States, Brand said. “The list prices for both products are markedly lower than the average sales price of their respective reference products, generating significant cost savings for patients and payers.”

Brand also stressed the importance of “scientifically accurate educational outreach” by regulators to promote stakeholder confidence in biosimilars and keep up the market momentum. “Competition is robust, biosimilar market share is increasing, and prices are coming down.”