New Mexico Senate Passes Bill for Biosimilar Substitution

Senators in New Mexico have passed a bill that will allow pharmacists in the state to substitute biosimilar products in place of the original or reference product, similar to what they currently are allowed to do with generic drugs.

The Albuquerque Journal reports that the state Senate voted 39-0 in favor of Senate Bill 180, which promises to give flexibility and control costs for some of the most expensive, and effective, biological products being used to treat a plethora of conditions—from cancer to rheumatoid arthritis to irritable bowel syndrome. The next step is approval of House Bill 260, now with the House Business and industry Committee in New Mexico.

The argument rests on drug costs. Between 2014 and 2016, the state-run Medicaid program saw a huge increase in the biological drug spend, which they associated with a 5% increase in state-funded plan members who were using adalimumab (Humira) and etanercept (Enbrel). The 2-year period saw a 52% increase in plan costs for those 2 drugs. Overall, state-run plans spent $13.3 million on anti-inflammatory agents in the year 2015—a 20% increase from 2014.

With budget impact in focus, lawmakers in New Mexico will debate whether pharmacists can substitute these expensive antibodies for cheaper “replicates,” and whether this substitution can lower consumer cost. This would require the blessings of the prescribing physician, who has the authority to write “no substitution” on the prescription.

The biosimilar approval process has been slow in the United States, with numerous legal and regulatory barriers preventing product application and launch. To date, just 1 biosimilar to adalimumab has been approved—Amgen’s Amjevita—but patent lawsuits will push product launch to 2018. Another product, manufactured by Sandoz, has delayed its abbreviated Biologics Licensed Application or aBLA.

Sandoz has also developed a biosimilar to etanercept (etanercept-szzs, Erelzi), but faces patent claims by Amgen, the developer of the original product.

Biosimilar competition will hopefully subdue the skyrocketing price of these biologicals. Abbvie, the manufacturer of Humira, has steadily raised the price of this antibody by over 70% in just a few years ($49,000 annually before discounts and $27,665 after discounts), likely due to broadening indications of the drug. Amgen has followed a similar route with Enbrel, which costs $4000 for a 30-day supply.