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.”
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Oncology Biosimilars Cut Costs; Diabetes and Other Diseases Could Follow
May 6th 2025Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.