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.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.