HONG KONG – It is not surprising that Tokyo-based Kyowa Hakko Kirin Co. Ltd. wants to hold on to Nesp (darbepoetin alfa), an erythropoiesis-stimulating agent used as a treatment for improving renal anemia, when the patent expires in 2019.

To that end, the Japanese biotech founded a new biosimilar subsidiary, Kyowa Kirin Frontier Co. Ltd., in a play to effectively ward off possible competition.

The new firm has been capitalized with ¥100 million (US$880,000) and is led by Chief Executive Wataru Maruta, formerly the director of corporate strategy and development at Kyowa Hakko Kirin.

“It is part of Kyowa Hakko Kirin’s management strategy,” Tomoko Kashiwabara, a spokeswoman for Kyowa Hakko Kirin, told BioWorld Today. “We decided that we need to find a biosimilar company, and at the same time we are aiming toward the approval and manufacturing of an authorized version of Nesp.”

The company will focus on developing and seeking marketing authorization for a biosimilar version. “Biosimilar products are not bioequivalent to brand name products. There are differences in the manufacturing quality and process, whereas an authorized version is the same product as the original brand,” explained Kashiwabara.

The company said an “authorized version” is an identical drug to the branded drug. It is most commonly used to describe an approved brand name drug that is marketed as a generic product without the brand name on its label.

The drug is identical in terms of active pharmaceutical ingredients, excipients and manufacturing method, and is manufactured and marketed by a company that receives the rights to exploit the branded drug’s patent from the company that owns the patent.

KEY REVERSE OPPORTUNITY

Last month, BMI Research published an industry trend analysis on Japan, noting that the evolving Japanese generic drug market will see authorized generic pharmaceuticals playing a larger role.

Those products can serve to further the commercial objectives of originator pharmaceutical firms, enabling them to compete against other generic substitutes for their long-listed medicines while outsourcing sales operations to the partnered generic drugmaker.

For generic pharmaceutical companies, authorized generics represent a key revenue opportunity that will augment their branding in an increasingly competitive subsector.

BMI also stated product differentiation to be a key commercial objective for pharmaceutical firms. That accentuates the importance of branding, with authorized generic drugs having a distinct advantage.

Currently, only two original brands of darbepoetin alfa, Amgen Inc.’s Aranesp and Kyowa Hakko Kirin’s Nesp, are marketed.

Nesp was developed as part of a collaborative research effort with Thousand Oaks, Calif.-based Amgen. Aranesp and Nesp had 2013 sales of $2.4 billion, making it unsurprising that biosimilar developers have targeted the drug. The patents for Aranesp are set to expire in Europe in 2016 and in the U.S. in 2024; the patent for Nesp is set to expire in Japan in 2019.

Nesp is designed to have a longer-lasting effect than conventional erythropoietin drugs. It is approved for improving renal anemia with reduced administration frequency. Merits of the drug include outstanding effectiveness in correcting anemia, along with a flexible dosage amount and interval, which have earned the trust of the pharmaceutical marketplace and a lead in market share.

Kyowa Hakko Kirin’s Nesp is currently marketed in Japan, South Korea, Singapore, Taiwan, Thailand, Malaysia, Hong Kong and Macau.

“In Japan, around 300,000 patients are affected by renal anemia,” said Kashiwabara. “At this moment we are planning to only sell it in Japan. We don’t have plans to expand out of Japan.”

The parent company, Kyowa Hakko Kirin, was founded in 1949. It is engaged in the manufacturing and marketing of pharmaceuticals. As the holding company of the Kyowa Hakko Kirin Group, it manages the business activities in the biochemicals segment.

South Korea’s Chong Kun Dang Pharmaceutical Corp. has been eyeing the biosimilar market for Nesp as well.

In January 2016, the company signed a licensing agreement with Fuji Pharma Co. Ltd. Under the agreement, Fuji Pharma has the exclusive rights in Japan for the development, manufacturing, distribution and sales of darbepoetin alfa biosimilar CKD-11101.