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Home » Topics » Drugs » Generic

Generic
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US FDA proposes updates to 21-year-old ANDA labeling guidance

Jan. 25, 2022
By Mari Serebrov
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would take a more proactive role in identifying and facilitating labeling updates, the U.S. FDA issued a draft guidance Jan. 25 intended to help holders of abbreviated new drug applications (ANDAs) keep their labels up to date with that of the RLD.
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Generic firms agree to pay $450M to resolve price-fixing allegations

Oct. 4, 2021
By Mari Serebrov
Three generic drug companies have agreed to pay a total of nearly $450 million to resolve U.S. Department of Justice (DoJ) price-fixing allegations.
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Teva tests CREATES path in Amicus suit

July 14, 2021
By Mari Serebrov
Putting the 2019 CREATES Act to the test, Teva Pharmaceutical Industries Ltd. filed suit July 13 against Philadelphia-based Amicus Therapeutics Inc.
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Generic drugs and bottle

Savings from complex generics remain elusive in U.S.

Feb. 10, 2021
By Mari Serebrov
Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.
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California dreamin’ of being generic, biosimilars player

Sep. 29, 2020
By Mari Serebrov
The governor’s signature brought California a step closer to realizing state officials’ dream of having their own generic and biosimilar drug label. In signing the California Affordable Drug Manufacturing Act into law Sept. 28, Gov. Gavin Newsom touted the legislation as a way to break down market barriers to affordable prescription drug prices. “Our bill will help inject competition back into the generic drug marketplace – taking pricing power away from big pharmaceutical companies and returning it to consumers,” he said.
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Amarin appeals the patent ruling on Vascepa vs. generics

Sep. 2, 2020
By Lee Landenberger
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
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Generic drugs and bottle

Shortages continue to belie generic Rx success story

April 15, 2020
By Mari Serebrov
Nearly 40 years on, the generic drug market is often lauded as an American success story. But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries.
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Will biosimilar carve-outs put R&D for older MAbs on ice?

Aug. 11, 2016
By Mari Serebrov
Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...
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Omontys Recall Rings Alarm Over Biosimilars

Feb. 27, 2013
By Mari Serebrov
Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.’s Omontys (peginesatide). Although Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes...
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Don’t Call Them Generics!

Jan. 29, 2013
By Mari Serebrov
When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...
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