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【Biosimilar Forum】The wall of AG for biosimilars- “Inhibiting the spread” pointed out one after another

2020年10月16日 (金)

The spread of biosimilars has become a significant issue as the next target after achieving a generic product usage rate of 80%. At the “Biosimilar Forum” held on the web by the Biosimilar Council on the 14th, symposiasts pointed out that the authorized generic (AG) of biosimilars that appeared last year hindered the spread of biosimilars. However, opinions were calling for a review of medical fees, including introducing incentives to promote use.

Active discussions in forums

For domestic biosimilars, 32 items of 14 ingredients have been approved by June this year, starting with the growth hormone preparation “Somatropin” developed by Sandoz in 2009. The market size is about 40 billion yen, about 20% of the total biopharmaceutical market. In 2017, the “Big-Boned Policy or Honebuto no Houshin” stated a plan to double the number of approved items at the end of this year on an ingredient basis, but it has already cleared the target.

However, the degree of penetration varies depending on the item. Although the usage rate of insulin glargine and filgrastim exceeds 50%, few patients choose infliximab.

On the other hand, in Darbepoetin Alfa, Bio-AG sold by Kyowa Kirin Co., Ltd. subsidiary occupies a little less than 70% share in hospitals and a little less than 50% share in non-DPC hospitals.

Yoshihiro Nambu, Chairman of the Japan Biosimilar Association, said, “Biosimilar is becoming more and more recognized, but we must remove the factors that hinder promotion.”

He also requested, “When bio-AG comes out, it will be unavoidable for companies to enter biosimilar products. I would like you to consider the position of bio-AG.”

Masaaki Miyakawa, Managing Director of the Japan Medical Association, said, “If generic biopharmaceuticals with same quality as the original product are priced lower than the biosimilars, biosimilar development will not be possible.” Regarding the name of generic biopharmaceuticals, he said, “There is confusion in the medical field and it is necessary to sort out. We must correct the divalent and trivalent values of one product, create an environment in which subsequent products can live, and build a scrum to realize drug development. ”

Junichi Kawakami, Vice Chairman of the Japan Society of Hospital Pharmacists, said that introducing the generic product index into the function evaluation coefficient II of hospitals in the medical fee revision in 2014 led to the spread of generic products. “Doctors in university hospital have also started to use generic products. The system will be a driver,” he said, calling for the introduction of incentives for the adoption of biosimilars.

On the other hand, there was an opinion that the handling of biopharmaceuticals and biosimilars should be considered more in medical fees. Professor Hiroyuki Sakamaki of Kanagawa University of Human Services said, “Biosimilars are eligible for addition in the home self-injection management guidance fee. Is it rational to do so?”. He insisted that a typical guidance fee to biopharmaceuticals should be introduced and those biosimilars should be added.

Toshihiro Hayashi, Director of the Ministry of Health, Labor and Welfare economic section, also said that industrial policy had delayed biopharmaceutical industry efforts. He indicated the necessity to foster the biopharmaceutical industry rather than specializing in biosimilar products.


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