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Forbidding Biosimilar Drugs Sales

biosimilar drugs

Supreme Court Capsized Lower Courts Decision of Forbidding Biosimilar Drugs Sales

On Monday, the Supreme Court’s justices capsized decision of lower court that forbid Novartis AG, the Swiss Pharma Comapany, from selling out biosimilar drugs of Amgen Inc’s Neupogen, based in California, for an extended six months period till FDA approves the drugs.

supreme court of U.S.
U.S Supreme Court

The biosimilar drugs can cure a wide range of diseases from diabetes, ulcerative colitis, breast cancer, Crohn’s disease, plaque psoriasis and rheumatoid arthritis. When at first Zarxio, cancer-fighting drug, flooded the market by costing 15% less than Neupogen drug, the sales of Neupogen dropped from one billion dollars to 765 million dollars back in 2015. Amgen sued Novartis in court for violating the Affordable Care Act through provision of biosimilars.

U.S. Supreme Court approved of sale of bio-similar drugs in the markets as it will cost the manufacturers millions of dollar in sales. The manufacturers of biologic drugs, that are in fact copycat versions of original drugs, do not have to wait for extended period of 6 months for approval to arrive from Food and Drug Administration to start selling the drugs, reported The Associated press and Fierce pharma.

Biosimilar drugs manufacturer will face million dollar loss in sales if they are kept off the market for six more months after twelve year time period of exceptionality for original biological drug manufacturers.

Original biologic drugs cannot be copied as they are isolated and manipulated from living organisms. Health insurance dealers expect copycat versions of biologic drugs to be sold at cheaper rates than original brands, as generics, which will save consumers around billion dollars yearly. Patient’s access to life-betterment treatments will accelerate, according to Novartis’ statement.

Drugs prices have been escalating as pharmaceutical companies have been irrationally over pricing drugs, criticized President Donald Trump as well. Trump has set goal to provide competition to pharma industry to bring down costs of drugs as it’s a huge matter of concern in terms of health of people.

drugs pilss

The case included the courts approval that if manufacturers of copycats of biologic drugs can conduct marketing for 180 days before the approval from FDA, which will speed up the process of bringing copycat drugs to the market.

Justice Clarence.Thomas  says that in simple language, the court has allowed the biosimilar drugs maker to market their product. Novartis AG has won in the case in favor of creating copies of Amgen biologic drug named Neupogen which boosts WBCs (white blood cells) in cancer patients.

U.S. Supreme Court’s decision for production of biosimilar drugs is justified if drug pricing is taken into account in contrast to importance of health factor for ever U.S. citizen. The pharmaceutical industry need to face competition to bring down the prices at more affordable rates.


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Shahzaib Amin Malik

Mr. Malik is the Managing Editor of Global Legal Review and a lawyer by profession. He is known as a speaker and extra technical skills in the field of law. He has shown a different view to the legal world and brought a diversified change in legal profession through his analysis and research in different fields of law. He is currently working on few of the biggest legal projects in the world which will bring value in the legal field globally.