Japan will Remain the World’s Second Largest Market for New Drugs and Patented Drugs after the U.S. at least until 2027 As described in the news article “国内医療用医薬品市場 27年度まで５年平均成長率、特許期間中の市場はプラス6.5～7.5％ IQVIA | ニュース | ミクスOnline (mixonline.jp)” released by MixOnline on June 26, 2023, IQVIA announced on June 23, 2023, the outlook for Japan’s pharmaceutical market for the fiscal year […]
Recommendations by MHLW to Facilitate the Early Introduction of New Drugs in Japan According to the news article, “有用性加算の柔軟化や類似薬拡大など提言 厚労省研究班、革新的新薬の早期導入で | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by NIKKAN YAKUGYO on June 16th, 2023, the 2022 annual report compiled by the team of Ministry of Health, Labour and Welfare’s scientific research on “Appropriate Research on the Development […]
“Increase Biosimilars with Over 80% Market Share to 60%” New Goal to Promote Biosimilars in Japan According to the news (バイオシミラー普及へ「シェア80%超成分を6割に」の新目標、市場拡大元年となるか | AnswersNews (ten-navi.com)) released by Answers as date of 05/06/2023, the Ministry of Health, Labour and Welfare has set a goal for disseminating biosimilars (BS). By the end of the fiscal year 2029, they […]
Japanese Pharmaceutical Market in the FY 2022 to Reach a Record High of 10.97 Trillion Yen According to the news article “2022年度の国内医薬品市場、過去最高の10.97兆円…前年度比2.6%増、コロナ薬・診断薬伸びる | AnswersNews (ten-navi.com)” released by AnswersNews on June 1st, 2023, IQVIA announced that the pharmaceutical market in Japan reached a record high in the fiscal year 2022, with a 2.6% increase from the […]
Regulatory Requirements and Drug Prices of Biosimilars in Japan As explained in the article, “バイオシミラー｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on November 21, 2018, a biosimilar is a drug with the same quality, safety, and efficacy as a reference biopharmaceutical product. It is developed by a different company (not the company that is marketing the […]
Basic Principle for Drug Prices in Japan In the article “薬価の基本｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on 07/06/2018, they explain the “YAKKA” (drug price) system in Japan, the official price of prescription drugs used in medical care. The price of drugs that are covered by public medical insurance is determined by the government (the Minister of Health, Labor and Welfare), and pharmaceutical companies cannot freely determine the […]
SAKIGAKE Designation System in Japan (similar to Fast Track/Breakthrough Therapy in the US) As described in the article “先駆け審査指定制度｜AnswersNews Plus (ten-navi.com)” released by AnswersNews on 15/03/2019, the SAKIGAKE designation system is a program that grants preferential treatment to innovative products such as pharmaceuticals, medical devices, regenerative medicine products, and in vitro diagnostic drugs that are applied for […]
VALIDANT GROUP ANNOUNCES NEW LEADERSHIP Tim Dietlin Joins the Company as CEO WASHINGTON, D.C. – The Validant Group, a leading international quality, compliance, and regulatory consulting firm, today announces that Tim Dietlin has joined the company in the role of Chief Executive Officer (CEO). “Tim brings a unique skill set to his role as CEO […]
HAE Product, BERINERT SC, Listed in NHI Pricing List CSL Behring’s BERINERT SC was approved for prevention of acute hereditary angioedema attacks, HAE, in September 2022. Efficacy and safety of the product based on results of COMPACT study, global Ph 3, COMPACT extension study and Japanese Ph 3 study were evaluated by PMDA. The duration […]
The 3rd PD-1 Inhibitor, LIBTAYO, approved in Japan Sanofi’s LIBTAYO, Cemiplimab IV, was approved in December 2022 Based on results of global Ph 3 EMPOWER-Cervical 1 study, of which duration was around 6 years. This is the 3rd approval for PD-1 inhibitor in Japan following Opdivo and Keytruda. It was approved to treat patients with advanced […]