Ahead of wrapping up a Phase III clinical trial for its proposed biosimilar denosumab candidate later this year, mAbxience has out-licensed marketing rights in Korea to local player HK inno.N, with a patent expiry opportunity in 2025.

Whether in the competitive world of US generics, the growing global biosimilars arena, or promising new geographical markets, Dr Reddy’s is seeking to capitalize on its strengths to remain competitive while also pushing forward with ESG goals, CEO Erez Israeli tells Generics Bulletin.

With Dr Reddy’s organization now spanning a range of innovative interests and CDMO activities as well as the firm’s traditional small-molecule generics and burgeoning biosimilars businesses, CEO Erez Israeli talked to Generics Bulletin about how these various areas were complementary thanks to the Indian giant’s ‘two-horizon’ approach.

Teva’s partnership with MedinCell for long-acting injectable products, first penned a decade ago, is beginning to gather steam, as another candidate entered the clinic ahead of a potential first approval in the coming months.

Sun has struck a $576m deal to acquire Concert Pharmaceuticals, picking up lead product candidate deuruxolitinib as part of an acquisition that advances the Indian firm’s specialty pivot.

Following Fresenius Kabi’s approval in mid-December for the eighth and latest biosimilar Humira (adalimumab) product, the company’s senior vice president for biosimilars in the US spoke to Generics Bulletin about how it can stand out from the pack and why it is confident that it can succeed.

The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.

An IGBA research report suggests international health bodies lack an accurate picture of global essential medicines shortages due to issues with monitoring and recording.

The burden of having to produce separate product packs for Great Britain and Northern Ireland is among a number of concerns raised by industry executives at a recent hearing in the House of Lords.

Germany’s Bundesministerium für Gesundheit is reworking the country’s off-patent drug legislation to allow for more flexible pricing.

With the US on the cusp of biosimilar competition to Humira, Julie Reed – executive director of the country’s Biosimilars Forum – has urged PBMs to bolster access by making all adalimumab biosimilars available as they launch throughout 2023.

Former employees at the Association for Accessible Medicines detail problems that emerged during Leonard’s tenure, but also say the board of directors must improve its management of the trade organization.

Generic medicines continue to be intentionally left off formulary tiers in favor of more expensive brand medications, according to a new report from the US Association for Accessible Medicines.

Sandoz has received a positive opinion from the EMA’s CHMP recommending that its high-concentration 100mg/ml adalimumab biosimilar be granted a pan-European marketing authorization. Three generics were also endorsed at the CHMP’s January meeting, including a rival to Forxiga.

Whether in the competitive world of US generics, the growing global biosimilars arena, or promising new geographical markets, Dr Reddy’s is seeking to capitalize on its strengths to remain competitive while also pushing forward with ESG goals, CEO Erez Israeli tells Generics Bulletin.

Ahead of wrapping up a Phase III clinical trial for its proposed biosimilar denosumab candidate later this year, mAbxience has out-licensed marketing rights in Korea to local player HK inno.N, with a patent expiry opportunity in 2025.

Amgen has confirmed its long-awaited launch of Amjevita, the first US biosimilar rival to Humira, kicking off a year of competition that will also see a second wave of adalimumab products launch in six months’ time. The company has announced that it will offer the product at a 55% discount to the originator.

Generic medicines continue to be intentionally left off formulary tiers in favor of more expensive brand medications, according to a new report from the US Association for Accessible Medicines.

Teva’s partnership with MedinCell for long-acting injectable products, first penned a decade ago, is beginning to gather steam, as another candidate entered the clinic ahead of a potential first approval in the coming months.

Fresh from offloading almost all its interests in biosimilars to Biocon, Viatris continues to develop several follow-on products, which it hopes will add $1bn to the company’s top line by the end of the decade.

The acquisition and consolidation mania that gripped industry in the middle half of the last decade may seem like a distant dream but players continued to spend cash where it could be justified in 2022, while raising much-needed capital to fund their endeavors.