Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.
Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.
With a US market that Mwamburi says is currently valued at $5.2 billion—and is projected to reach $28.2 billion by 2020—biosimilars are becoming a more attractive investment opportunity for reference product sponsors. While makers of originator products have thus far attempted to retain market share through a variety of defensive strategies—“We’ve seen this through legal barriers being raised, and extensions of patent protection,” said Mwamburi—the coming patent cliff has forced sponsors to think about what Mwamburi calls “bi-vesting,” or diversifying revenue streams by moving into the biosimilars space. The future of biologic therapies, said Mwamburi, “…is going to involve a lot of buying, selling, and licensing between companies.”
An originator developer’s investment in biosimilars can involve 1 of 3 strategies for sharing risk and revenue: acquiring a biosimilar company, entering into a partnership with a biosimilar developer, or entering into a licensing partnership on a regional or global scale. He highlighted partnerships and acquisitions involving Pfizer—Celltrion, Novartis–Sandoz, and Amgen–Allergan as representatives of the emerging “symbiotic dynamic.”
Whether they occupy the originator biologic or biosimilar space, drug makers should carefully consider the value that they bring to a potential partnership before solidifying a deal, said Mwamburi.
Originator biologics developers’ considerations should include the following:
Biosimilar developers open to acquisition or partnership should:
Mwamburi sees the growing trend of investment on both sides of the reference and biosimilar divide as a positive trend for the industry; “Any variations in how [the legal] tug-of-war is going to happen is going to quickly stabilize” as drug makers learn how best to approach the issue of biosimilar market entry. He foresees patent negotiations eventually moving more quickly, and predicts that there will be more drug companies engaging in faster, less costly negotiations instead of litigation. “With those barriers getting out of the way, you’ll find the influx of biosimilars coming in.”
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
Commercial Biosimilar Coverage Is on the Rise, but Preferences Still Vary
October 28th 2023A poster from AMCP Nexus quantifies trends in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still vary.