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.”
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
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.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.