The approval of Biocon Ltd. and Fujifilm Pharma Co. Ltd.‘s biosimilar version of insulin glargine in Japan is significant, some experts say, given that the first such biosimilar from Eli Lilly & Co. and Boehringer Ingelheim GMBH appears to have made early gains in the Japanese market, indicative of a general acceptance for biosimilars there.

The Lilly/BI product was approved at the end of 2014 and launched in 2015, providing the first local biosimilar competition to Sanofi‘s Lantus ([A#28150118002]).

Biocon's ready-to-use, prefilled disposable pen with 3ml of 100IU insulin glargine is expected to be launched in the first quarter of fiscal 2017. The partners aim to capture a significant share of the $144m Japanese glargine market - the second largest outside of North America and Europe and largely dominated by disposable pens, a company statement said.

"There would be a pricing discussion that happens and the launch of the product is subsequent to that and that should happen in the next couple of months," Biocon's CEO, Dr. Arun Chandavarkar, told PharmAsia News’s sister publication Scrip Intelligence in a media call on March 28 when asked about reimbursement pricing for the product.

On the potential impact of Sanofi's Lantus follow-on product Toujeo (insulin glargine), a next-generation insulin, already on the Japanese market, Chandavarkar maintained that the he does not believe that the product would "influence" the launch of the firm's biosimilar of Lantus.

"To penetrate a market with a novel product or new formulation of a product there needs to be a significant clinical benefit. And if the significant clinical benefit is commensurate with the price point - basically it's an outcomes issue. My understanding is that insulin glargine would continue to be a dominant product in the Japanese market and likewise elsewhere in the world as well," he said.

Toujeo was approved in Japan last year to be sold under the trade name Lantus XR.

Biocon said that approval for insulin glargine followed its successful completion of initial development and local Phase III clinical studies in over 250 Type 1 diabetes patients by its partner in Japan.

The Indian firm's manufacturing facilities for insulin glargine, and the disposable pen assembly facility have been approved by the Japanese regulatory authorities - latter was inaugurated in September 2015 for the launch of Biocon’s insulin glargine pen branded as Basalog One in India.

Competition, Market

While the approval for the biosimilar is seen as a significant achievement for Biocon and Fujifilm, experts underscore that the Indo-Japanese alliance will find itself up against well-entrenched competitors.

Ripple Mehta, senior consultant at MP Advisors, an Indian strategic business advisory firm, told Scrip that the Biocon/Fuji alliance will have to deal with a formidable competitor in Lilly/Nippon Boehringer Ingelheim, whose Lantus biosimilar has attained 9% volume share in Japan, post two months of launch last year.

That is the second highest such share by a biosimilar insulin glargine after what was seen in Slovakia and more than in any other EU market where the biosimilar has been launched, Mehta explained.

"The early penetration of biosimilar Lantus in Japan is indicative of the growing acceptance of use of biosimilars there. Lilly/Nippon Boehringer Ingelheim have a very strong foothold in the Japan diabetes market. We expect biosimilar Lantus to penetrate well in the market, in line with the likes of erythropoietin biosimilar. Biosimilar Lantus has the potential to attain volume market share of 40% in the next three years" Mehta told Scrip.

The Japan diabetes market is valued at JPY400bn ($3.52bn) and growing at 6% annually, data from MP Advisors show.

Mehta also noted that while the Lilly/Boehringer biosimilar products are approved, under the NHI reimbursement system, at about 56% (for the syringe version) and 67%(pen delivery version ) of the originator's price, the Fuji/Biocon prefilled disposable pen could also probably "get 67% of the originator price as they did a Phase III study in 250 Japanese patients."

(This article also appears in Scrip Intelligence. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)

Biocon/Fujifilm Enter Lantus Biosimilar Fray In Japan

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