The article, “FDA Struggles To Foster An Affordable Biosimilar Insulin,” was featured in the IP section of Law360
Green Griffith co-founding partner Caryn Borg-Breen offers pharmaceutical industry insights in her article, “FDA Struggles To Foster An Affordable Biosimilar Insulin,” published in the Intellectual Property section of Law360.
The piece notes market pressures to make insulin more affordable as prices have increased almost 600% in the last 15 years.
Caryn explains that, despite the popular perception that anti-competitive behavior in the industry alone has led to higher prices, the current regulatory environment, which handles insulin differently from other biologics, also plays a significant role in driving prices higher and limiting the ready availability of interchangeable substitutes.
She writes, “While the rise in insulin prices might partially be due to patent-related monopolies involving new insulin delivery devices or insulin analogs, it’s more significant that insulin products are not (currently) subject to abbreviated approval pathways that foster ‘generic’ or ‘biosimilar’ competition. There is no pathway for ‘biosimilar’ insulin because although insulin products are biologics, they are regulated under the Food, Drug & Cosmetic Act and not the Public Health Service Act. They are thus outside the purview of the Biologics Price Competition and Innovation Act (BPCIA).”
Regulatory reform could hold the key to changing the insulin market, she explains, concluding, “It’s an exciting time in the world of biosimilars and it will be exciting to see what the FDA does next regarding insulin products. In the meantime, patients with diabetes continue to await progress towards a more affordable drug regime.”
To read the article in its entirety from Law360, click here.
For a PDF version of the article, click here.
Learn more about Caryn here.