TOKYO – A flurry of activity over the past month suggests that the adoption of biosimilars in Japan is about to accelerate. Partnerships with Indian and U.S. companies are bringing new biosimilars to the market, while an association for the drugs was launched to help promote awareness of their benefits.

Fujifilm Pharma Co. Ltd. earlier this year released a biosimilar insulin glargine onto the Japanese market after licensing it from the Indian company Biocon Ltd. as part of a broader push in Japan to bring cheaper versions of biopharmaceutical treatments to patients. "Sales of the drug are going well and [it has been] well accepted," said Kana Matsumoto, of Fujifilm's corporate communications division.

The treatment, which is similar to Sanofi SA's Lantus, received approval in March and was released into the market last month. It is still too early to tell whether the release in Japan of the insulin biosimilar will be successful, but Kiran Mazumdar-Shaw, Biocon's chairman and managing director, said she was confident the agreement would bear fruit.

"We believe with Fujifilm Pharma's commercial network, we will enable access to this world-class, prefilled disposable pen for better diabetes management for patients in Japan," she said.

Glargine is registered by Biocon in 20 countries, and a biosimilar is expected to begin selling in Malaysia early next year, after recently receiving approval from authorities in Kuala Lumpur to put the drug on the market. The Japanese market for glargine is worth around $144 million and treats around 7.2 million people afflicted with the disease, according to the International Diabetes Federation.

For Fujifilm, the deal with Biocon may prove to be a one-off, as it has a joint venture with Kyowa Hakko Kirin Co. Ltd. to develop and launch biosimilars in Japan. "There is no decision on whether FujiFilm Pharma will license-in other insulin [products] from Biocon," Matsumoto told BioWorld Today.

Still, its release in Japan shows that companies in the Northeast Asian nation, and the government, are looking for ways to cut costs beyond cutting the prices of drugs on the National Health Insurance scheme and introducing simple generics to the market. Biosimilars are one option.

In April, the Japan Biosimilar Association (JBSA) launched with a mission to get more products to the market through information exchange, research and lobbying. The organization will include six committees tackling drug safety, research and development, public relations, general affairs, health care systems and matters relating to medicine. Its first chairman is Tatsuo Kurokawa, a former bureaucrat at the Ministry of Health, Labour and Welfare.

The JBSA's first four members are Nichi-iko Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Meiji Seika Kaisha Ltd. and Mochida Pharmaceutical Co. Ltd. "Both the benefits and definition of biosimilars are yet to become common knowledge in Japan," Kurokawa said upon taking the chairmanship of the new association.

Outside of the new association, Daiichi Sankyo Co. Ltd. and Thousand Oaks, Calif.-based Amgen Inc. last month signed an agreement to commercialize nine biosimilars to Japan, including those for adalimumab (Humira, Abbvie Inc.), bevacizumab (Avastin, Roche Holdings AG) and trastuzumab (Herceptin, Roche Holding AG). Financial terms for the agreement were not disclosed, but Daiichi Sankyo will handle marketing approval, commercialization and distribution in Japan, while Amgen maintains control of manufacturing and development responsibilities. (See BioWorld Today, July 18, 2016.)

Fujifilm's Matsumoto views the biosimilar market as having potential.

"The biosimilars market is set to expand rapidly throughout the world against the backdrop of escalating medical costs and patent expiration of a series of innovative biopharmaceuticals through to 2020," she said.

Targeting the market, Fujifilm Kyowa Kirin Biologics Co. Ltd., was launched in 2012, equally co-funded with Kyowa Hakko Kirin. The joint venture currently has two biosimilars in development, one for adalimumab and another for bevacizumab. The company aims to become a leader in biosimilars by combining Kyowa Hakko Kirin's pharmaceuticals technologies with production and quality control methods used by Fujifilm during the years when it was primarily a manufacturer of photographic film. It was launched with ¥100 million (US$998,223) in capital.

The biosimilar for adalimumab, which treats rheumatoid arthritis, is currently in phase II trials in countries including the U.S. The biosimilar for bevacizumab, which can be used to treat colorectal and non-small-cell lung cancers, is in phase I trials in Europe. Last year, Fujifilm Kyowa Kirin Biologics set up a joint venture with Astrazeneca plc, of London, to get the drug to market. In exchange for allowing the new venture to market the drug, the Japanese company received a payment of $45 million. (See BioWorld Today, Aug. 4, 2015.)

While the market for biosimilars is likely to grow, Matsumoto said the drugs and technology will not likely face the same sort of commoditization that has damaged the market for standard pharmaceuticals. "Biosimilars will require an advanced level of reliability and quality equivalent to that of their original counterparts as well as low costs in order to achieve broad proliferation and expansion," she said.