"The FDA will continue to pay attention to the incidents of original research drug manufacturers' malicious defamation of biosimilar drugs, especially the safety and efficacy of original research companies' 'intentional confusion' of biosimilar drugs.We will take action if we discover which company deliberately misleads the public."(Screenshot from FDA Secretary's tweet)
Recently, an article published in the Washington Post stated that health care and government officials are increasingly worried that the original research companies have used various" intimidation "to prevent patients from choosing generic drugs in order to protect profits.This will not only lead to patients will fall into the original research and generic drugs "protection battle", while adding to the cost of state control of health insurance expenditures.
The generic drugs mentioned in the article mainly refer to biosimilar drugs cultivated from living cells.Although the FDA has proven that approved drugs are safe and effective, some original research companies have "educated" doctors to make doctors suspicious of these cheaper "imitation" drugs.
Scott Gottlieb, FDA Director, admitted in an interview, "I am concerned that brand companies are deliberately or unintentionally trying to create confusion about the safety and efficacy of unbranded biopharmaceuticals, especially for patients and physicians who are considering" original research alternatives, "and this information may undermine consumers' confidence in biosimilar drugs in unreal ways."
Gottlieb did not disclose the name of the specific company or group.But there are some warnings about biosimilars from some highly profitable innovative drug manufacturers.For example, "they may pose additional risks," "may send you to the ICU," and "potential problems involve efficacy and safety," Gottlieb said that if the FDA did not issue a warning letter to these similar drug manufacturers, only the original research intentionally misled the public, the FDA will take action.
Gottlieb is willing to do so, there are analysis that mainly from the point of view of control fees.Data show that in the next 10 years, US health care spending will increase from 54 billion US dollars to 200 billion US dollars, and controlling the cost of biological agents is crucial to compress US health care spending.
It is estimated that between 2010 and 2015, 70% of the increase in prescription drug costs in the United States came from biologics, while drugs such as Humira of AbbVie led the way.According to the non-profit organization Rand Corp.In a study, it is expected that the price of these similar drugs will be reduced by 10% to 51%.
Despite the fact that biosimilar drugs have been available in Europe for many years and have drastically reduced the cost to consumers in Europe.But in the US, unbranded biosimilars are still relatively new.The European Medicines Agency has approved more than 40 biosimilar drugs.According to the FDA official website, after the FDA approved the first biosimilar in 2015, only 16 products have been approved so far.
FDA approves biosimilar drugs by analyzing their structure and reviewing data from human testing, and clearly states that there is no clinically significant difference in safety, purity, and potency between approved products and original research drugs.
"Biosimilars are different from chemical generics.Biopharmaceuticals are proteins grown in a fermenter, not a combination of simple chemicals.The complexity of biopharmaceuticals makes it difficult for manufacturers to reproduce the original research, and little changes will occur during the cultivation process... ".Similar preaching by the original research firm has raised doubts about effectiveness or safety.
Some lobbyists' reasons also include, "Biosimilar drugs may disrupt your continuity of treatment and may cause you to enter the emergency room, be hospitalized, or even the ICU, may exacerbate or cause your other illnesses, and the use of biosimilar drugs may have different effects than the original study …".
The industry association BIO, which is critical of biosimilar drugs, spends more than $10 million a year lobbying the federal government; followed by the two largest US biopharmaceutical companies.The three agencies are financial supporters of the Alliance for Safe Biologic Medicines, a non-profit organization that aims to curb the spread of unbranded biosimilars.
The Washington Post stated that the common way of the alliance is to play bitter drama, reminding the medical community that patients should be carefully and carefully transitioned from original research drugs to biosimilar drugs to avoid the occurrence of similar "thalidomide" events.However, there are currently no recommendations for the use of biosimilar drugs in the United States or Europe for any such health effects.
Last summer, Pfizer submitted a document to the FDA accusing Amgen, Genentech and Janssen Bio of misleading doctors and patients on "alternative" issues.Pfizer acquired biosimilar drug manufacturer Hospira in 2015.
The messy message coupled with the chaotic reform movement has been going on for many years, and as the market competition is closer to reality, it has therefore attracted more attention.Corey Cutler, an oncologist at the Dana-Farber Cancer Institute who has consulted biosimilar drug manufacturers, said that marketers of biologics have attacked imitation manufacturers more aggressively online, even if FDA and biosimilar drug manufacturers are helpless.