The Pharma Letter published its U.S. biosimilars watch last week with views from three industry leaders who agreed that despite great anticipation, biosimilars have been slow to market in the U.S. and that there are parallels to generic small molecule drugs that had similarly slow growth in the 1980s, but now account for nearly 90 percent of prescription drugs in the U.S.
Pharma Letter identifies five important areas impacting biosimilars in the U.S.:
1. Regulatory approval and market entrance
2. U.S. legislative activity
3. Patent disputes
4. Antitrust disputes
5. Physician and patient education
Five of the nine biosimilars approved in the U.S. gained market access last year by the U.S. Food and Drug Administration (FDA), none are “interchangeable.” Currently 60 biosimilars are enrolled in the FDA’s Biosimilar Development Program; more biosimilars are likely to be approved in 2018 and beyond.
Yet it is still uncertain when biosimilars will take hold in the U.S.; as only three of the nine approved biosimilars are currently marketed and available for patient use. The future of biosimilars that meet the interchangeable designation is also unclear, although the FDA appears to believe that interchangeables are close to emergence.
On the legislative front, 37 states and Puerto Rico have enacted laws regulating substitution of interchangeable biosimilars. At the federal level, Congress has addressed both biosimilars and generic drugs during its 2018 budget discussions but holes exist with respect to biosimilar testing and approval processes and the pending Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
Patent disputes on biosimilars have gone to the Supreme Court – last year they resolved the Amgen v. Sandoz case permitting a biosimilar applicant to opt out of the “patent dance” procedure through which the reference biologic and the biosimilar applicant are expected to exchange various disclosures. The Supreme Court made another biosimilar ruling which gave biosimilar applicants more control over how patent disputes are addressed, allowing applicants to decide whether to disclose an application earlier or later along the approval process.
The final question regarding biosimilars is acceptance by physicians and patients. The FDA published a series of materials in 2017 to educate healthcare professionals about biosimilars and interchangeables. Additionally, the FDA is now conducting additional research to identify useful information to help improve communications between health care professionals and patients.
Despite these hurdles in the U.S., The Pharma Letter wrote that a new report from MarketsandMarkets predicts biosimilar medicines will reach a value of $23.63 billion by 2023, up from $5.95 billion in 2018 – expanding at a compound annual growth rate of 31.7 percent.
Read The Pharma Letter article, US biosimilars watch: similar but not deja vu here.