Five events in the biopharmaceutical industry in 2017

Source: International Pharma 2018-01-19 this paper summarizes five major events in the field of biological similar drugs in 2017 These five events reflect a series of measures taken by many stakeholders in the pharmaceutical industry to establish a good framework for promoting the development of bio similar pharmaceutical industry In the process of development, the above measures may have a positive impact on the development of biopharmaceutical industry, but they will also generate some problems and industry barriers As in 2016, there have been many major events in the biopharmaceutical industry in 2017, such as Scott Gottlieb as FDA director These events have provided opportunities and challenges for the bio similar drug industry, regulatory agencies and the pharmaceutical industry as a whole 5 The Federal Trade Commission (FTC) held an antitrust seminar FTC held an antitrust seminar focusing on the industry of generic drugs and biological similar drugs, which is unprecedented In the past year, we have heard more and more about the so-called abuse of power in the supply chain, including the receipt of kickbacks and the lack of transparency in the interest chain of middlemen When analyzing the development of biopharmaceutical industry, in addition to data charts, a large number of visual aids such as slides have been used to highlight the capital flow and income of stakeholders in the supply chain The FTC seminar brings together generic drug manufacturers, bio similar drug manufacturers, pharmacy benefit managers (PBM), group purchasing organizations, distributors, trade organizations, pharmacists and academicians to listen to their views on the current situation of the industry This workshop introduces the current situation and problems of supply chain in pharmaceutical industry, and explains the important role of bio similar drug manufacturers in anti unfair competition FTC made it clear that the change of anti-monopoly law may not happen immediately or at all (in July 2017, the Democratic Party of the United States called for the change of the anti-monopoly law of the United States and the amendment of the "consumer welfare center theory"), but the discussion of this event in the public forum is the beginning of attention, which will become a solution to the impact on the development of biological similar drug industry when the market is mature Key factors 4 Pfizer sued Johnson & Johnson for unfair competition On September 27, 2017, Pfizer filed a lawsuit against Johnson & Johnson in the federal court of Philadelphia, the United States, accusing Johnson & Johnson of using exclusive contracts to promote its arthritis treatment drug REMICADE (generic name: infliximab, infliximab), and attacking the Pfizer biological similar drug infactra (infliximab) This is the first lawsuit in the field of biological similar drugs in the United States The lawsuit attracted wide attention from the industry, in part because Pfizer itself is an innovative company, and it must have adopted the same approach as Johnson & Johnson in the market competition However, from this unresolved case, it can be seen that this is a tug of war between industry innovators and bio similar drug manufacturers in terms of market share Johnson & Johnson has a positive attitude towards the commercial defense strategy of biological similar drug infractra, by setting up exclusive contracts in nearly half of the market, binding a large number of hospital drugs and facilities together, and providing more discounts to large infusion centers to seize market share However, 2017 is a year when the industry began to pay attention to market barriers It is only a matter of time before the court required Johnson & Johnson to implement the contraction strategy or modify the exclusive contract 3 The settlement of patent litigation between abbvie and Amgen in 2017 is a year of continuous patent disputes, which is also a year when we start to see a turnaround In March, we saw a settlement between mylan and Genentech, a subsidiary of Roche, over the patent issue of trastuzumab, a breast cancer drug Mylan obtained Roche's global license for its trastuzumab analogue (excluding Japan, Brazil and Mexico) In September, the solution to the patent infringement lawsuit between American Pharmaceutical Company Ai Bowei (AbbVie) and biopharmaceutical Amgen was the non exclusive patent license granted by AbbVie to Amgen's Amjevita (common name: adalimumab-atto), which took effect in the U.S market on January 31, 2023 This not only gives abbvie six years of additional patent protection (a total of 20 years), but also brings many challenges to the bio similar drug industry These challenges undoubtedly stem from business competition Amgen is likely to add a clause to the settlement: if other companies launch Humira's bio similar drugs by 2023, Amgen will launch amjevita ahead of time Therefore, no one can escape from the "patent maze" set by abbvie intact Similarly, if we don't see the launch of Humira biosimilars before 2023, it means that we are studying a biosimilars without clinical patient basis in six years Because Humira has a prominent position in the market and has a large number of clinical patient base, we must realize that it is very risky for bio similar drugs without clinical patient base to enter the market suddenly If the price of Humira continues to rise in the next six years, we have to use the six-year waiting period to think about the pricing of bio similar drugs 2 On January 17, 2017, FDA issued the draft guiding principles for interchangeability of biological similar drugs Although the principle of interchangeability did not immediately cause much controversy (unlike the still controversial guidance on the naming of biological analogues), it has been realized that the principle of interchangeability may discourage the industry Researchers are faced with some challenges in the search for high equivalence between biological analogues and original products, including similarity comparison test, real-world evidence and clinical trial subjects In general, the industry generally believes that FDA's high "threshold" for pharmaceutical companies (in this case, pharmaceutical companies need to submit cumbersome application materials to FDA when conducting exchangeable tests) may prevent them from conducting exchangeable tests of similar biological drugs In addition to the above concerns, some actions of regulators have inadvertently led some people to mistakenly believe that the quality of interchangeable bio similar drugs is higher than that of non interchangeable bio similar drugs Although interchangeability can provide potential commercial value for pharmaceutical companies, it remains to be seen whether the release of this guideline will enrich the U.S market for bioequivalent drugs 1 If there is one thing that can summarize the positive progress in 2017 in the biological similar drug industry, it is the amendment of Part B legislation by CMS CMS encourages and supports the use of bio similar drugs by providing medical institutions with the same compensation as the use of bio products in the medical catalog, and takes a series of measures to increase the use of bio similar drugs, so as to reduce the cost of drugs Since CMS first released the relevant policies of Medicare Part B bioequivalent drugs in 2016, each bioequivalent drug has its own unique j-code (consumption code) which will become one of the development goals of bioequivalent drug industry (j-code means that all bio generic drugs are reimbursed at the same rate, which limits competition and slows down price fluctuation After each bio similar drug has its own unique j-code, the reimbursement rate will be different, thus further promoting market competition) After CMS revised Part B, the industry worried that replacing the original research drug with "bio similar drugs" to control drug expenditure would eventually lead to the complete withdrawal of the original research product from the biological product market At the same time, the industry expects that this change will induce generic manufacturers to participate in the market of biological similar drugs.