TOKYO – Hoping to combine the affordability of biosimilars with the promise of combination cancer therapies, London-based Astrazeneca plc is making its first foray into biosimilar development through a joint venture with Fujifilm Kyowa Kirin Biologics Co. Ltd. (FKB).

Both parties will contribute equal shares to the yet-to-be named venture that's targeting blockbuster cancer drugs, with FKB receiving a lump sum payment of $45 million for transferring the rights to its FKB238 biosimilar to the venture.

One of two biosimilars being developed by FKB, which itself is a joint venture between Japan's Fujifilm Corp. and Kyowa Hakko Kirin Co. Ltd., FKB238 references Roche AG's Avastin (bevacizumab), a VEGF ligand inhibitor. Approved to treat about 30 types of cancer, Avastin generated more than $7 billion in total global sales last year, according to Cortellis Regulatory Intelligence.

Although the monoclonal antibody is surrounded by a multitude of patents, the key patents protecting Avastin are expected to expire in 2019 in the U.S. and 2022 in the EU.

While several other biosimilar sponsors are looking to cash in on Avastin's sales, Astrazeneca sees a bevacizumab follow-on as an opportunity to advance its own pipeline of innovative combination cancer drugs. "Developing an interchangeable biosimilar of bevacizumab adds another building block for our innovative combinations approach in oncology that will enable lower cost of therapy that could otherwise be prohibitively high," Astrazeneca's Tokyo spokeswoman Takako Mitsui told BioWorld Today.

Having access to a lower priced Avastin biosimilar will enable Astrazeneca "to develop and commercialize combinations that would otherwise be too expensive for a large number of payers globally," Mitsui added.

While the joint venture is Astrazeneca's first foray into biosimilars, Mitsui said, "we remain focused on innovation, developing our pipeline of potential small-molecule and biologic medicines to treat a range of cancers." But the agreement will allow Astrazeneca "to explore potential novel combination therapies that will not be prohibitively expensive and therefore limit patient access," she added.

Less expensive combinations could fill a need in a lot of countries. "For nationally funded health care systems, a treatment that offers a better price-performance ratio has to be good news," Hugh Ashton, a Japan-based industry watcher told BioWorld Today. "It allows more patients to be treated more effectively, and the FKB-Astrazeneca tie-up on this particular biosimilar will be welcomed in many markets. With FKB's expertise in developing biosimilars, and Astrazeneca's global market reach, we may expect FKB238 to be a worldwide success."

The new joint venture will accelerate the global development and commercialization of FKB238, given Astrazeneca's strength and expertise in the oncology market, said Hiroki Nakamura, manager of Kyowa Hakko Kirin corporate communication department in Tokyo. FKB began development of the biosimilar last year and anticipates its launch in about five years.

In addition to the Avastin biosimilar, FKB is developing FKB327, a biosimilar to Abbvie Inc.'s Humira (adalimumab). The follow-on is in phase III trials for rheumatoid arthritis.

At least 25 companies have announced plans to develop or are developing Avastin biosimilars, according to BioWorld's report Biosimilars: A Global Perspective of a New Market – Opportunities, Threats and Critical Strategies 2014. One of the furthest along is ABP 215, which is being developed by Amgen Inc. and Allergan plc.