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Value-Added Medicines

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Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Biosimilars Value-Added Medicines

Judges Weigh Record Entries Ahead Of October’s GGB Awards

Now in its tenth year, the Global Generics & Biosimilars Awards has received a record-breaking number of entries in 2023. Judges are now evaluating the nominees ahead of our awards ceremony on Wednesday 25 October at the Hotel Porta Fira in Barcelona.

Generic Drugs Biosimilars

Teva’s Francis: I Looked At All The Sexy Stuff And Overlooked Olanzapine

After launching the Uzedy long-acting formulation of risperidone in partnership with MedinCell earlier this year, Teva has stressed the “really exciting” product profile of another long-acting antipsychotic from the partnership, olanzapine, while discussing how it will avoid the safety pitfalls of legacy products in the space.

Value-Added Medicines Strategy

What’s Next? Five Things To Look Out For In September

Generics Bulletin previews the most notable and anticipated events for September 2023.

Biosimilars Generic Drugs

Outlook’s Ophthalmic Bevacizumab Knocked Back By FDA

Outlook Therapeutics has received a CRL from the US FDA over its application for an ophthalmic formulation of bevacizumab. The company says it is working with the agency to address the various issues raised.

Value-Added Medicines Biologics

One Week To Go: Final GGB Awards Entry Deadline Looms

There is now just over a week to go until the final deadline for entries to the Global Generics & Biosimilars Awards 2023.

Generic Drugs Biosimilars

Viatris Welcomes FDA Date On Slow-Release Copaxone Product

Viatris and Mapi have moved a step closer to realizing the US launch of their 505(b)(2) once- monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis.

Value-Added Medicines Drug Review

Henlius Announces Positive Phase I/II Results For Ophthalmic Bevacizumab Biosimilar

Henlius has successfully established the safety and preliminary efficacy of its ophthalmology-indicated bevacizumab biosimilar HLX04-O in Phase I/II trials.

Clinical Trials Biosimilars

One Month Remains To Enter 2023 Awards

Just one month remains for contenders to submit their entries for consideration in the Global Generics & Biosimilars Awards 2023.

Generic Drugs Biosimilars

Generics Bulletin’s Top 50 Ranking For 2023

This article compiles all of the data from Generics Bulletin’s 2023 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

Generics Bulletin Top 50 Sales & Earnings

The Generics Bulletin Top 50, Part Three: Final Firms Enjoy Mixed Fortunes

In the third part of this year’s Generics Bulletin Top 50, we look at how various increases and declines for companies at the bottom of our table have affected their positions in the ranking.

Generics Bulletin Top 50 Sales & Earnings

The Generics Bulletin Top 50, Part Two: Mid-Table Firms Move Up And Down

In the second part of Generics Bulletin’s Top 50, we look at the mid-table players and how they have shifted positions this year.

Generics Bulletin Top 50 Sales & Earnings

The Generics Bulletin Top 50, Part One: Indian Leaders Climb Into Top 10

In a year that has seen significant changes throughout our generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders after two other firms dropped out of the top table. We delve into what has changed in the first instalment of this year’s Generics Bulletin Top 50.

Generic Drugs Biosimilars

What’s Next? Five Things To Look Out For In August

Generics Bulletin previews the most notable and anticipated events for August 2023.

Biosimilars Generic Drugs

What’s Next? Five Things To Look Out For In July

Generics Bulletin previews the most notable and anticipated events for July 2023.

Biosimilars Generic Drugs

Podcast: The Global Generics & Biosimilars Awards 2023

With entries currently open for the Global Generics & Biosimilars Awards 2023 – which will take place on Wednesday 25 October at the Hotel Porta Fira in Barcelona – we talk through the categories that companies can enter, tips to make entries stand out, as well as the benefits of entering and attending the awards.

Generic Drugs Biosimilars
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