On Jan. 1 2013, Abbott Laboratories split into two companies, one retaining the Abbott name and the other named AbbVie. As a result, Abbvie took over development and marketing of Humira. You know, the drug you have seen all the time on television ads,
The brand name ”Humira” stands for human monoclonal antibody” in rheumatoid arthritis.
Humira is a product derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeasts.
FDA standards to give approval for a biosimilar are based on showing that it is highly similar to an already-approved biological product and has no meaningful differences from them of safety, purity, and potency from the reference products. It can only be licensed for use for the same indications and conditions that have been approved for the reference product.
In the case of Humira, and its biosimilar, there are now nine such indications including rheumatoid arthritis., psoriatic arthritis and Crohn’s disease.
Kiran Panasewr, a freelance medical writer in U.S.Pharmacist published October 14, 2016, defines bio-similar as one of two types of biological products that have been designed to provide an alternative to currently marketed biologics, the other being known as interchangeables.
Whose fault is it when a company obeys the law and figures out a way to extend the patent and rights to a new drug, a biological drug which is a name of an entire class of drugs that are made in a totally different manner than anything that came before them, and really work, and not just in a palliative manner. It is nobody’s fault and the company’s should be complemented, not attacked
Generic drugs are not the same as biosimilars, but like generics, biosimilars are less expensive than the original drugs that they are considered to be an alternative for. An example would be Adalimumab, a biosimilar for Humira.
Unbranded biologics are different from typical generic medicine. Instead of a combination of chemicals, biologic drugs are grown in vats from living proteins. This complexity makes it impossible for a generic manufacturer to make a replica of the brand medicine: Production results in small variations..
Those molecular-level variations give brand companies and allied groups, writes Christopher Rowland in the Washington Post on Jan.9th, 2019, an opening to sow doubt about effectiveness or safety.
Biologics have an exclusivity period for twelve years from the date of first licensure under conditions outlined by the “Affordable Care Act”.
Now, Amjevita, a trade name for Adalimumab, which we all know as Humira, from watching television and reading ads in the papers and magazines we read is introduced,
Adalimumab was originally developed through a joint venture between Cambridge Antibody Technology and BASF in the UK, writes Barbara Gilmore in Focus,” Transforming Clinical Trials”2018.
Danny Hakim, writing in an article in the New York Time, Jan. 6, 2018, writes of Amgen and Abbvie agreeing to a global settlement allowing commercialization of Amjevita that will grant patent licenses for the use and sale of Amjevita worldwide on a country-by-country basis, but the companies have agreed to dismiss all pending litigation.
Amgevita is the first adalimumab biosimilar to be approved by the European Commission.
It is authorized for the treatment of inflammatory diseases in adults including moderate to severe rheumatoid arthritis, psoriatic arthritis, severe active ankylosing spondylitis, moderate to severe plaque disease, moderate to severe Crohn’s disease and moderate to severe ulcerative colitis.
The biosimilar, amgevita, launched in Europe on Oct. 16, 2018 and will launch in the US on Jan. 21, 2023.
Rowland writes in the Washington Post, “Abbvie, whose anti-inflammatory drug, Humira, is the biggest seller in the world by revenue, is facing questions from congress about alleged anti-competitive practices. Critics say the company has created “patent thickets” around its drug that discourage “generic”: competition. The drug manufacturer has also cut deals with the makers of biologic copies to keep them off the market until 2023.”
FDA standards to give approval for a bio-similar are based on showing that it is highly similar to an already-approved biological product and has no meaningful differences from them of safety, purity, and potency from the reference products. It can only be licensed for use for the same indications and conditions that have been approved for the reference product.
In the case of Humira, and its bio-similar, there are now nine such indications including rheumatoid arthritis., psoriatic arthritis and Crohn’s disease.
Lisa Gill,Writing in Consumer Reports, January 2020, says” putting all the blame on Big Pharma is an oversimplification,” Drug costs are also driven by a drug supply, system with middlemen, shrinking insurance coverage. PBMs or Pharmacy Benefit Managers, who work with health companies to create a formulary, a list of the drugs the plan agrees to cover.
The drug companies offer “rebates” to get their drugs on the PBM formulary. This is not something new. Companies always offered large “potential users” of their drugs a better price to get on the formulary of the hospital, insurance companies formulary, etc. Gill writes “in other industries, that might be considered an illegal kickback,
But in the early 1990s, the Department of Health and Human Services, HHS, authorized by Congress, wrote an exception for these rebate payments to federal anti-kickback laws. That allowed drug companies to use the payments as a negotiating tool, according to Stephen Schondlmeyer, a professor of Pharmacoeconomics at the University of Minnesota in Minneapolis.
The good news is that “high prescription drugs are at least being discussed at all levels of government and industry. The bad news is” there is no“One size fits all” solution to the problem,”.
Bertram Drachtman
Great Neck
