Biosimilars are experiencing the same situation as generic drugs
Biosimilars, which were once highly anticipated by the industry, have now been abandoned by multinational pharmaceutical companies.
On January 27, Bojian announced that it would sell shares in the joint venture to Samsung Group for a total value of US$2.3 billion.
Bojian and Samsung, which were previously jointly funded and established by Samsung, are one of the world's largest biopharmaceutical CDMO companies. At the same time, in the past 9 years, Samsung Biology has 6 biosimilars of rancidumab, bevacizumab, trastuzumab, adalimumab, infliximab and etanercept.
Bojian holds a 49.9% stake in the joint venture, and the sales revenue of biosimilars also comes from this. In particular, sales revenue increased slightly in the two years, reaching $831 million in 2021. But what annoys Bojian is that the patent issue of biosimilar drugs has led to a large number of lawsuits.
With the intensification of market competition, Bojian has begun to realize that biosimilars are a business with large investment and low profits. Under the transfer agreement, Bojian will continue to assist Samsung Biologics in the future in the sale of biosimilars.
Abandoning the development of biosimilars seems to be the same choice for many multinational pharmaceutical companies. Since 2017, several companies such as Pfizer, Merck, Sandoz, Merck, Andringer Ingelheim have gradually abandoned some biosimilar businesses.
Today, biosimilars are repeating the history of the generic era. The industry generally believes that the collapse in prices and the reduction of profits will directly reduce the enthusiasm of multinational pharmaceutical companies to invest in research and development.
Multinational giants are starting to abandon biosimilars, but Chinese companies are still taking action.
Many pharmaceutical companies gave up and could not meet the needs of profits
As the world's most promising product type, the market size of biosimilars is expanding day by day. Analysis of a number of securities companies: the global biosimilar market size will exceed 35 billion US dollars in 2021.
However, the other side of the coin is that the huge market size has also attracted fierce competition among companies. BoJian admitted in its 2021 annual report that due to the continuous listing of biosimilars, the revenue of rituximab will continue to decline.
The market outlook is uncertain, and for Bojian, whose annual sales have exceeded the $10 billion mark, the biosimilar drugs sold for less than $1 billion are undoubtedly chicken ribs, and it seems more secure to choose to sell and liquidate in the end. Under the contract, Samsung must pay off the $2.3 billion stake acquisition over three years.
Bojian, Pfizer, Sandoz, Boehringer Ingelheim and many other multinational pharmaceutical companies are gradually abandoning biosimilars. From hot to cold, the biosimilar boom lasted less than 10 years.
Back in 2017, Merck sold the biosimilar to Fresonius for $195 million; in October 2018, Merck and Samsung Bio terminated the development of the insulin "Come and Go" analogue, even though the drug had been approved by the FDA.
Just a month later, Sandoz abandoned its regulatory application for The Biosimilar Rixathon in the U.S. market. Around the same time, Boehringer Ingelheim also said the company was shrinking its global biosimilar business, focusing only on the United States.
In March 2021, Pfizer announced that it would stop producing biosimilars in China and sell its production site to WuXi Biologics.
All of this can be attributed to the fact that in July 2018, the FDA issued an action plan to encourage the marketing of biosimilars, which aims to reduce the retail price of biological products in the United States. According to FDA data, if the FDA had approved all biosimilar marketing applications at that time, the U.S. health care expenditure in 2017 could have saved more than $4.5 billion.
Through administrative intervention, the FDA has lowered the market price of biological products, which is similar to the mainland's collection.
A large number of similar products have been listed, profits have dropped sharply, and the development of biosimilars has encountered obstacles. Analysts pointed out that once the price of the original drug is reduced by 60%, coupled with the brand recognition accumulated over the years, it is difficult for biosimilars to earn sweetness in the competition in a short period of time.
More critically, according to the approval process of existing countries, the listing application of biosimilar drugs needs to do "head-to-head" tests with the original research drugs, which is different from chemical generic drugs. This alone has raised the cost of biosimilar research and development.
According to Henlius' announcement, R&D investment in 2017 and 2018 totaled 622 million yuan. The company's co-founder Jiang Weidong once said that as the country's first biosimilar drug, "Hanlikang" needs to purchase the original research drug to complete the head-to-head test.
It is difficult for the product to be approved for listing, but the market retail price has decreased year by year, and the expected profit cannot be obtained, which is the fundamental reason why major pharmaceutical companies are no longer optimistic about biosimilar drugs. What's more, it is believed that the "virtual fire" of the biosimilar industry should be lowered.
Entering a transition period, the biosimilar market has undergone tremendous changes
A large number of biosimilar drugs are listed internationally, which is actually related to the development of China's pharmaceutical industry.
In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage The Innovation of Pharmaceutical Medical Devices, which clearly supports the development of biosimilar drugs.
Since then, a large number of Chinese companies have invested in the research and development of biosimilars. According to public data, as of December 2019, there are about 400 biosimilar research and development pipelines in China, and about 180 companies are laying out biosimilars.
A large number of Chinese innovative pharmaceutical companies have laid out biosimilar drugs, and in addition to the attention of domestic competition, they have also "gone to sea" to affect the pattern of the European and American markets.
Collection of biosimilar drugs, which is the content identified in the state-run document in early 2021. According to the 2022 plan of the National Medical Insurance Bureau, the total number of drugs collected at the national and provincial levels should reach more than 350, and the collection and collection of chemical drugs, biological drugs and proprietary Chinese medicines should be promoted in an all-round way.
The 2021 insulin collection can be seen as a biosimilar drug collection in a broad sense. At the end of November 2021, the results of the special collection of insulin were released, and 42 products of 11 companies were selected, and the highest product price reduction was more than 70%.
Looking at the global pharmaceutical industry, biosimilars are competing with innovative pharmaceutical companies for limited market resources, and not all pharmaceutical companies can survive, and not all pharmaceutical companies can pay for the "high cost" and "low profit" competitive pattern.
Expanding globally has become the only way out for China's innovative pharmaceutical companies.
According to Thomson Reuters data, the number of preclinical biosimilars in the mainland exceeds that of the United States, and the number of core patents also ranks third in the world, second only to the United States and the European Union. The patent problem is an unavoidable problem for biosimilars, and many multinational pharmaceutical companies rely on patent barriers to hinder the listing of biosimilar drugs.
In addition, the field of biosimilars is also facing technical difficulties, and its production process and quality control are highly complex and challenging. Because of this, the investment cost of biosimilars is higher than that of chemical drugs.
In the face of an uncertain market, multinational giants have begun to retreat first, how long will Chinese companies hold out?
Text | millet
Operational | Twenty-thirteen
Two in-depth manuscripts per day to decode medicine and health
#Multinational pharmaceutical companies ##三星生物 #
Established at 8%.
On January 30, the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Health Commission and other nine departments jointly issued the "14th Five-Year Plan" Pharmaceutical Industry Development Plan, which pointed out the direction for the development of the industry in the next five years.
The main tasks in the "14th Five-Year Plan" of the pharmaceutical industry have become more pragmatic, vigorously promoting innovative research and development, requiring the global market, focusing on new targets, and encouraging enterprises to actively carry out research and development layout.
The state explicitly encourages the development of new technology platforms such as antisense oligonucleotides, small interference RNA, and protein degradation technology (PROTAC), requires the development of new antibody biological drugs such as ADCs and multifunctional antibodies, and encourages the development of cell therapies and gene products such as CAR-T and CAR-NK. At the same time, the layout of new crown, HPV and other multivalent vaccine products.
The industry revenue indicators of the 14th Five-Year Plan have been slightly lowered. During the "13th Five-Year Plan" period, the average annual added value of China's pharmaceutical industry was 9.5%, which is almost close to the "annual revenue growth of 10%" established by the Ministry of Industry and Information Technology and the former National Health and Family Planning Commission in 2016 in the "Guidelines for the Development planning of the pharmaceutical industry".
However, in this "14th Five-Year Plan", the average annual growth rate of revenue and profit established by the state for the pharmaceutical industry is more than 8%.
#14th Five-Year Plan ##医药工业 #