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 Environment, Stable Supply, and Distribution Environment of Drugs” provided a comprehensive overview of the research related to maintaining and improving the appropriate development, stable supply, and distribution environment drugs.
The report presents specific recommendations aimed at facilitating the early introduction of new drugs. Firstly, the flexible application of the usefulness-addition criteria is proposed. The low application rate of usefulness addition is highlighted as a concern, particularly for orphan and pediatric drugs where conducting randomized controlled trials can be challenging. The proposal suggests evaluating the application of usefulness addition based on appropriate indirect comparison data. Furthermore, it emphasizes the importance of considering not only the primary evaluation parameters in clinical trials but also the patient’s quality of life and patient-reported outcomes.
The report also emphasizes the importance of ensuring predictability in drug pricing. To achieve this, the report suggests expanding the range and approach of similar efficacy comparison methods, enabling a more comprehensive selection of reference drugs (most similar drugs). It further advocates for enhancing the pre-consultation system regarding drug price calculation. Additionally, it recommends applying foreign average price adjustment even for price increases after listing and considering additional add-ons for products with simultaneous launches in Japan, Europe and the United States.
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 aim to increase the replacement rate of reference products to BS, of which market share exceeds 80%, to 60% on a quantity basis. Currently, 16 ingredients of BS have been approved, but only three ingredients, epoetin-α, filgrastim and darbepoetin-α, representing less than 20%, have achieved a quantity share of 80% or more. It is said that the dissemination of BS will take time and may follow a similar path as generic drugs. While concerns about quality are settling down, there is still a lack of stability in the supply of imported products, and cases of shipment adjustments and suspensions exist. Currently, only three ingredients exceed a quantity share of 80%, and there are challenges in increasing the percentage of those ingredients. The introduction of authorized generics (AG) has quickly increased the overall share of BS, but price competition has eroded companies’ financial strength, posing challenges for investment recovery and supply continuity. Cost-effectiveness is crucial for achieving the government’s target, and companies with a consistent system from in-house manufacturing to sales can reduce costs. However, sourcing from other companies may take time to secure profits. To promote wider dissemination, incentives in the medical fee reimbursement system and alleviation of economic burdens are necessary, but the previous policies have not yielded satisfactory results. Ensuring a stable supply is also essential, as it becomes difficult to gain the trust of physicians and patients in situations of supply instability. The dissemination of BS is still in its early stages and faces various challenges to be addressed.
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 previous year, totaling 10 trillion and 969 billion yen (approximately 80 billion USD at the current exchange rate). The demand for therapeutics and diagnostics for the treatment of COVID-19 contributed to this growth. Ono Pharmaceutical’s immune checkpoint inhibitor drug, “Opdivo,” remained at the top for the second consecutive year in product sales. All three market segments, including hospitals, clinics, and pharmacies, experienced growth. Among therapeutic categories, “anti-tumor agents” generated the highest revenue. The COVID-19 pandemic also led to a significant increase in demand for diagnostic test reagents, propelling them to the top 10 therapeutic categories. From January to March 2023, the market recorded a 1.3% increase, reaching 2 trillion and 591 million yen (approximately 20 billion USD), while diagnostic test reagents experienced a substantial decrease. In terms of product sales, “Opdivo” maintained its top position, followed by “Keytruda” and “Eliquis.” Among the pharmaceutical companies, Chugai Pharmaceutical retained its leading position, followed by Takeda Pharmaceutical and AstraZeneca.
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 originator) after the patent for the reference product has expired. To demonstrate clinical equivalence and similarity to the reference product, clinical trials enrolling actual patients are required even if the development process of biosimilars is not equivalent to that of the reference product. The price of a biosimilar is typically higher than that of a typical generic product due to the high costs associated with development and manufacturing. However, it is typically 70% of the price of the reference biopharmaceutical product. For subsequent biosimilars, the price tends to be proportional to the price of biosimilars already on the market. And also, current updates on government policy indicate a supportive trend for biosimilars.