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With drug prices on the rise, more affordable copies of brand-name drugs play an important role in the market. This section offers content pertaining to the manufacturing, regulatory and market challenges faced by generics, as well as their biologic counterparts, biosimilars.

Articles

Charting a sustainable path for generics

Key takeaways from the Association for Accessible Medicines’ Access! 2024 meeting

Assuring generic access evermore

Generics’ longevity hinges on steady, straightforward storytelling

Nevertheless, they persisted

How drugmakers are fighting to keep reproductive health drugs available, safe and legal

Fresenius Kabi snags its first biosimilar approval

Stimufend is now the company’s first approved U.S. biosimilar, but the sixth FDA-approved biosimilar for pegfilgrastim

Another brick in the fall: Pharma’s biggest hit is granting licenses to patents

Music wouldn’t be quite as interesting without the legal histrionics of rock bands.In addition to having one of the best-selling albums in U.S. history, Pink Floyd is also known...

News

Novartis confirms Sandoz spinoff rumors

FDA approves first fully interchangeable Lucentis biosim

Teva enters the ring with generic Revlimid

Samsung Biologics buys Biogen’s stake in biosims venture for $2.3B

Prestige BioPharma, Dr. Reddy’s partner on Herceptin biosim

Amgen snags big win in ongoing biosim battle

Novartis could part ways with Sandoz

Novartis is mulling a sale or spin off of its generics business, Sandoz.

Drug deals: Casting the role of the ‘bad guy’

When headlines began calling out the “largest cartel in the history of the United States,” people kept reading

Legal unease

How the generics industry is adjusting as the dust settles on price-fixing lawsuits

FDA approves first ophthalmology biosim

Biogen and Samsung Bioepis announced that the U.S. FDA approved Byooviz, their biosimilar to Roche Holding's blockbuster eye drug Lucentis

Global Dose: Focus on Australia

While the R&D and clinical world has stayed on the cutting edge of modern medicine, the country’s manufacturing industry has slipped through the cracks of Australia’s economy....

USAntibiotics brings penicillin production back to the U.S.

When Neopharma shuttered a 43-year-old Bristol, Tenn. plant last year, the closure left the U.S. dependent on China for critical antibiotics.

GSK's win over Teva could spell trouble for 'skinny' labels

The U.S. Court of Appeals for the Federal Circuit ruled to reinstate GlaxoSmithKline's $235 million wins against Teva for patent infringement, after a years-long legal back-and...

10 major drugs falling off the patent cliff in 2021

At some point, the patent cliff claims the high-rolling life of market exclusivity for all drugs — and 2021 is, of course, no exception.Although the industry has been flushed ...

Advocacy groups seek federal intervention as clock ticks on closing of U.S. generics plant

Viatris is set to close the doors on its West Virginia manufacturing plant at the end of the month, but labor and advocacy groups are urging the Biden administration to use the...

Supreme Court rejects Novartis Enbrel patent appeal

The U.S. Supreme Court declined to hear Novartis’ challenge to two patents on Amgen's rheumatoid arthritis blockbuster, crushing hopes of Novartis launching a biosimilar in the...