Educational Briefing on Biosimilars for State Legislators
Thursday, May 28, 2015
MichBio facilitated an education briefing “Overview Breakfast: Biosimilars – NextGen Therapies” on behalf of the Michigan Biosciences Legislative Caucus. The one and a half hour event was held on May 21, 2015 at the meetings facility at Government Consulting Services, Inc. in Lansing. The purpose was to address biologic drugs, their interchangeability, and substitution with biosimilars.
The briefing came on the heels of legislation introduced by Rep. Ken Yonkers (R-Caledonia) – H.R. 4437. MichBio, along with the Discovering Cures Coalition made up of biotech and pharmaceutical manufacturers (both branded and generic), patient advocacy groups, and some pharmacy benefits managers, under the auspices of Discovering Cures, opposes the bill since it lacks sufficient requirements for transparency and communication about biosimilars substitution.
The first speaker, Michael Malecki, PhD, Director, Research and Development Policy - Biosimilars, Amgen, gave a primer on biologic drugs and how they compare traditional small molecule entities. Then he described biosimilars and how they differ from generic drugs. Given that biologic products are considered large molecules and are made from living cells, they must invoke clinical trials to understand the risk vs. benefit between them and the biosimilar.
Patrick Plues, Senior Director, State Government Affairs, BIO spoke next about how biologics must be treated differently than generics and need heightened approval standards. He reviewed the five principles that BIO advocates are needed for the substitution of biologic products. The 1st, 3rd, and 5th principles listed in the BIO Principles for Biologic Substitution are currently laws for generic drugs but the states need to update laws to cover biologics. The 4th principle concerning pharmacist and doctor communication has caused the biggest debates in state legislatures.
Opponents, mostly pharmacist associations and major drugstore chains, say the communication requirement is burdensome and unnecessary. They also believe biologics are covered by existing generic laws. The pharmacy associations are fighting the principle of communication between pharmacist and doctor if a biosimilar is substituted for the reference product.
Andrew Schepers, Director, Michigan Government Relations at the American Cancer Society Cancer Action Network, provided the patient perspective. He reinforced the need for informing a physician of a biosimilar substitution to ensure the best possible care and treatment efficacy and safety for patients.
Over 25 legislators and/or staff attended the briefing, in addition to numerous MichBio member biopharma companies.
Biosimilars substitution legislation that includes BIO’s five principles is planned to be introduced by Rep. John Bizon, MD (R-Battle Creek) in the near future. MichBio will support that legislation, but it will require considerable advocacy in Lansing to educate legislators on the subject.