Manufacturers of biosimilars view delivery device flexibility in draft US Food and Drug Administration (FDA) guidance as a means to gain an edge against competitors and innovator products. West is keen to encourage this pursuit of novel delivery technologies and talked up the benefits at its investor day.
“Delivery devices are key differentiators for biosimilars”, Mike Schaefers, vice president of marketing, Europe at West, said. Meeting demand for alternative delivery devices would allow West to tap into the significant growth potential of the biosimilars market.
As well as targeting established markets West is looking to Asia-Pacific for biosimilars growth. Later at the investor day Warwick Bedwell, president, Asia-Pacific at West, said “relatively lax regulatory systems” and strong local companies in the region make it a growth market for biosimilars.
Optimistic growth targets are supported by interest in device flexibility since the FDA posted its draft. In March William Marth, CEO of Teva Americas, welcomed the device choice flexibility in draft FDA guidance, saying it “makes a lot of sense”.
Since then innovator biopharma firms have hit back. Novo Nordisk, Pharmaceutical Research and Manufacturers of America (PhRMA), and others used the FDA biosimilar comment docket to voice concerns about the safety implications of the flexibility.
“Intentionally introducing differences to the molecule or the finished product will increase the level of uncertainty regarding the proposed biosimilar’s similarity to the reference product”, Jeffrey Francer, assistant general counsel at PhRMA, wrote in feedback to the FDA.
Opposition from innovator companies is unsurprising given the threat biosimilars pose to these firms’ leading products. While an overturning of device flexibility provisions in the FDA draft could hurt West, it is also poised to benefit from the defensive actions taken by innovator biopharma firms.
As patent expiration dates for key biologics approach West expects companies to perform lifecycle management in an attempt to extend the sales generating lifespan of successful drugs. Alternative, more convenient delivery devices are one option and West wants to tap into this opportunity.
The pivotal growth trigger for West though is adoption of its range of Crystal Zenith vials and syringes that can help manufacturers stop overfilling and cut the risk of breakages. However, while West has seen strong interest in the products, it is taking time for this to convert into significant sales.
“Progress is slow for regulatory and practical reasons. Injectable pharmaceutical manufacturers must produce two-year stability data before requesting FDA approval for commercial sale in the new format”, David Windley, equity analyst at Jefferies & Company, wrote.