Originator Biologics Manufacturers "Bi-Vest" in Biosimilars

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:

• Trends in the treatment of diseases
• Financial projections for particular disease indications
• The pipeline landscape for potentially competing products
• The capabilities of the biosimilar developer that the company may want to acquire

Biosimilar developers open to acquisition or partnership should:

• Conduct internal research on the true value of their product
• Enhance the value of the company or portfolio beyond the biosimilar molecule itself
• Ensure that proper contract negotiations take place
• Customize their product for competitive scenarios

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.”