Partnerships have been vital for success in the biosimilars segment. Strategic partnerships have valuable due to multiple compounding factors – time–sensitivity of the development journey, regulatory complexity and need for medical detailing due to low clarity on interchangeability. Strategic partnerships have also helped defray high level of risk intrinsic to slower than anticipated regulatory support and dragging pace of market maturity.
The latest partnership story in the biosimilars saga is a significant one – Teva and Alvotech. Alovotech is a poster child for accelerated and capital efficient portfolio development. Alvotech’s pipeline contains several biosimilar, monoclonal antibodies and fusion proteins targeting a range of severe immune and inflammatory conditions, oncology and ophthalmology. Teva, on the other end, is one of the world’s larger generic companies that hadn’t dug too deep into biosimilars as yet. The latest announcement combines Teva’s marketing strength with Alvotech’s pipeline in the highest value geography, US.
Per the latest announcement, Teva and Alvotech’s partnership entails an exclusive relationship for commercialization of 5 undisclosed biosimilars from Alvotech’s pipeline in the US market. Combining value of innovator revenue from these five biologicals aggregates to about USD 35 billion.
Teva’s foray into the biosimilars market happened only in 2019 with its partnership with Celltrion for marketing its Truxima (rituximab) and expanding in 2020 Herzuma (trastuzumab). The latest partnership marks a significant development for Teva, powering the generic major with a strong foothold in the rapidly emerging US market for biosimilars. It now joins the league of other small-molecule generics focussed pharma companies seeking a share of the biosimilar market in the light of steep pricing pressure and cut-throat competition in US generics. Timing of this partnership is highly opportune. The biosimilars’ commercial opportunity finally appears tangible: heightened regulatory appetite with multiple biosimilar approvals and launches in 2020 as well as FDA’s transition of certain drugs such as insulin to biologic, a long overdue reform needed to encourage biosimilar development.
Mylan was one of the first major generics focussed companies to dive deep into the world of biosimilars. Building on the strong foundation of small-molecule generics, Mylan has now positioned itself as one of the market leaders in biosimilars. The company has nurtured one of the industries’ largest and most diverse biosimilars franchise. Strategic partnerships have been critical in this pathway to accelerated development and revenue realization. Mylan’s many partnerships include Biocon, Momenta and Revance. Sandoz, the generics arm of Novartis has also been a forerunner in the biosimilars race. In the next wave of generic companies pursuing biosimilars include contenders from India, Aurobindo Pharma, Intas and Cadila Healthcare. As the generic companies embrace a higher level of risk and vie for a share of the expanding biosimilars opportunity, innovator biotech companies continue to enhance their own level of investments in biosimilars. With Amgen as a stark example of the latter category, the complex biosimilars stage only gets more exciting. Hopefully, increased competition only implies wider access to affordable biologic drugs, and patients have the last word.