Biosimilar Drugmakers Score Huge Victory With Supreme Court Ruling
The court, in a unanimous ruling, ruled that companies making biosimilars don't have to wait an extra six months after gaining Food and Drug Administration approval before selling the drugs.
Stat:
In Amgen-Sandoz Case, Supreme Court Rules To Allow Lower-Cost Biosimilars To Market Faster
In a highly anticipated decision, the U.S. Supreme Court reduced the time that companies will have to wait before selling lower-cost versions of expensive biologic medicines, a move that is expected to save the health care system piles of money. The 9-to-0 ruling came in response to sharply contrasting views of the complex procedures found in the Biologics Price Competition and Innovation Act, which is supposed to determine when biosimilar drugs can be launched. In this instance, Sandoz and Amgen are squabbling over competing interpretations. (Silverman, 6/12)
The Associated Press:
High Court Ruling Speeds Up Generic Biotech Drug Approval
A unanimous Supreme Court is speeding up the time for generic biotech drugs to become available to the public in a ruling that means a loss of billions in sales to the makers of original versions. The justices ruled Monday in favor of generic drug maker Sandoz in its dispute with rival Amgen over a near-copy of Amgen’s cancer drug Neupogen. (Hananel, 6/12)
The Hill:
Supreme Court Rules To Speed Marketing Of Lower-Cost 'Biosimilar' Drugs
The decision is a huge victory for other biosimilar manufacturers. Biologics are an ever-increasing share of the U.S. drug market. They are made from living cells instead of chemicals and, as a result, they can't be copied to make generic versions. But while they've helped advance disease treatments, they can be expensive. (Weixel, 6/12)
In other news about generics —
Stat:
When Will Truvada Will Go Generic? Teva Won't Say, Per Settlement
A mid widespread confusion over when the HIV prevention pill will go generic, a spokeswoman for Teva on Monday told STAT that the company has reached a confidential settlement controlling when it can enter the marketplace. ... The Food and Drug Administration last week approved Teva’s bid to sell the first generic pill for the HIV prevention method known as pre-exposure prophylaxis, or PrEP. That news initially brought excitement and hope in the HIV/AIDS community that the new option would usher in lower prices. (Robbins, 6/12)
