TOKYO – Despite numerous obstacles standing in the way of companies making progress, Japan's biosimilars market is likely to grow in the coming years, driven both by rising awareness of the value of no-brand drugs and an industry body that is driving growth.

But companies looking to sell biosimilars in Japan will have to make sure that their sales infrastructure reaches multiple channels to ensure drugs get to patients, according to Business Monitor International (BMI). "Fundamentally, firms will have to actively engage physicians, pharmacists and patients to gain acceptance for their biosimilar products."

Japan can be a challenging market for nonbranded drugs, said Ang Wei Zheng, Asia-Pacific pharmaceutical and health care analyst at BMI. (See BioWorld Today, June 22, 2016.)

"Brands have always been an important part of the Japanese pharmaceutical market," Zheng said. "Even in the case of generic drugs, a survey by the Chuikyo [Central Social Insurance Medical Council] between October and December 2014 noted that 22.3 percent of GPs and 18.6 percent of hospital doctors specified generic brands because they had doubts about the quality of generics other than a select few brands. It is highly likely that this dynamic will apply to biosimilar products as well."

Sales representatives play a major role in getting drugs to Japanese consumers. The number of sales staff in the country increased from 56,000 in 2007 to 66,000 in 2013, according to the Medical Representative Education and Accreditation Center of Japan.

But change may be underway.

"Growing government and media scrutiny of the relationship between life sciences companies and health care providers is expected to drive more transparency, changing long established practices in personal promotion to providers by pharmaceutical company representatives," noted Deloitte's Jun Matsuo in a report last year.

For now, though, companies will need sales representatives to get their biosimilar products into the hands of customers. BMI points to the launch in July of the Japan Biosimilar Association, a new organization that lobbies the government, raises awareness of the drugs and finds ways for members to cooperate, as a growth driver.

"Though nascent, the establishment of the Japanese Biosimilar Association in July 2016 marks a notable step forward for the class of medicines as it creates a platform to advocate its use," BMI noted. "Counting several Japan-based companies such as Nichi-Iko Pharmaceutical and Nippon Kayku as its members, the association aims to bring together the industry, government and academia to determine the role of biosimilars in Japan's health care system and discuss the obstacles to their acceptance."

"In terms of the new association, certainly there is significant potential for the grouping," Zheng said. "They can play a major role in articulating the position of biosimilar firms in the market."

Nine biosimilars are currently available in Japan – three for filgrastim, two for insulin glargine and one each for epoetin alpha, infliximab, darbepoetin alpha and somatropin. The first to be approved – Sandoz Inc.'s somatropin – reached the market in 2009. Since then, approvals have never exceeded three in any given year. (See BioWorld Today, July 20, 2016.)

Part of the problem, according to BMI, is the stringent conditions companies have to meet to obtain approval for biosimilars.

"Firms seeking to gain approval for their biosimilar products face tougher requirements than generic drugs," BMI wrote. "Beyond the need to show similarity between the biosimilar candidate and the reference product, regulators also recommend that people of Japanese ethnic origin be included in any one of the comparative pharmacokinetic and efficacy studies used in the submission."

Despite such obstacles, however, more biosimilars are expected to reach the market soon.

Lupin Ltd., India's third largest pharmaceutical maker, is expected to file for approval of its biosimilar of Enbrel (etanercept), Amgen Inc.'s psoriasis and arthritis drug, which has a global market worth $5.36 billion and is marketed by Takeda Pharmaceutical Co. Ltd. in Japan. The biosimilar etanercept is in phase II trials.

Lupin formed a joint venture, YL Biologics, with Japan's Yoshindo Inc. in 2014 to help get the biosimilar to market. According to Kamal K. Sharma, vice chairman of Lupin, YL Biologics reflects Lupin's long-term commitment to the Japanese market and is a crucial first step to establishing Lupin's global biosimilar portfolio.

According to Deloitte, "a push from payers, which has yet to be seen, may help open up the market" for biosimilars. The company, however, noted that in terms of access to biologics and regulations, Japan is a favorable market for companies.