Review Addresses Obstacles to US Biosimilar Entry and Uptake
Although 14 biosimilars have now been approved by the US Food and Drug Administration (FDA), only six have reached the market and questions about the viability of the biosimilar industry in the US have been raised.According to a review published by Ameet Sarpatwari and others from the Department of Medicine at Brigham and Women's Hospital and Harvard Medical School in Clinical Pharmacology & Therapeutics, there are several steps FDA and lawmakers can take to ensure the health of the biosimilar industry, particularly to address issues in manufacturing, regulatory and marketing.
“Despite the small number of products that have entered the market and their modest cost-savings to date, biosimilars have the potential to play an important role in containing rising US prescription drug prices,” the authors write. “To achieve this promise, policymakers must address existing manufacturing, regulatory, and marketing barriers to market entry and uptake, including trade secret protection of critical manufacturing information, pre-approval testing requirements, a lack of interchangeability guidance, patent thickets, rebate traps, and physician and patient skepticism.”
On the regulatory end, the authors call for FDA to coordinate with other regulators from the EU, Canada and Australia to “create uniform pre-approval study requirements with the ultimate goal of a single application dossier that would be sufficient across all jurisdictions.”
In addition to international harmonization, the authors note another way to level the playing field between biosimilars and their reference products on the manufacturing front would be if Congress passed new legislation that would condition FDA approval of originator biologics on disclosure of manufacturing trade secrets in biologics license applications upon expiration of the 12-year regulatory exclusivity period.
“The complicated and costly process for manufacturing biosimilars greatly reduces the number of potential manufacturers that have the technical expertise and market capitalization to make a high-quality product that would pass the FDA’s exacting standards,” the authors write.
And in the absence of FDA action on interchangeability, or the approval of any interchangeable biosimilars, the authors note that states could modify their drug selection laws to authorize a state board of pharmacy to determine whether automatic substitution of originator biologics with biosimilars would be appropriate in particular cases.
Physician and patient skepticism around biosimilars, meanwhile, could be mitigated by disseminating materials that address outstanding questions about biosimilar safety and effectiveness and by rescinding FDA’s current “confusing” naming policy, they write.
“Use of such suffixes is not necessary for product-specific surveillance; CMS already requires submission of unique national drug codes for reimbursement of all pharmacy-dispensed medications and unique Healthcare Common Procedure Coding System J-codes for reimbursement of physician-administered biosimilars which can be harnessed in claims-based observational investigations.”
The authors also point to inter partes reviews, which worked for Hospira and others in the past, as a valuable tool for biosimilars manufacturers.
Review