Generics

The Polish player has won two grants sourced from the government’s National Recovery and Resilience Plan, which has given out $28.1m in funding in the latest round.

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

Teva will have to wait until the end of the next decade to launch its proposed generic version of Axsome Therapeutics’ Auvelity treatment for MDD.

Biocon reported another quarter of sluggish generics revenues but hopes that planned generic liraglutide launches and US facility expansion will grow this business segment.

Reporting global Entresto sales of more than $7.8bn in 2024, Novartis spoke to investors on the latest legal dynamics for its best-selling product as the threat of US generic competition from MSN Laboratories continues to loom.

In its first meeting of 2025, the EMA’s CHMP issued positive opinions recommending marketing authorizations for Eylea and Neulasta biosimilars from Amgen and Aurobindo, as well as a Revolade generic from Accord.

Breckenridge will take a step further into accessible medicines and launch its first prescription copay assistance program for its freshly approved generic everolimus tablets.

Lannett will recognize the validity and enforceability of pair of US patents shielding the tablet formulation of J&J’s Uptravi (selexipag) blockbuster until 2030, under a consent judgment and order of permanent injunction signed by a judge in a federal district court in Delaware.

Amneal builds on its affordable medicines business with three FDA approvals – two final and one tentative – for generic rivals referencing AbbVie’s Namzaric, Novartis’ Afinitor Disperz, and Bausch Health’s Xifaxan.

China’s National Healthcare Security Administration has responded to reports of complaints from Chinese healthcare professionals about the quality and efficacy of generics purchased through the country’s volume-based procurement scheme.

As the generic drug industry warily watches another transition process for propellants in metered-dose inhalers, the US FDA is urging companies not to discontinue development because they are afraid of being caught in the switch.

In the aftermath of last week’s J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin’s editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry.

Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.

ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.

The FDA delivered its “Christmas gift” of approving Hikma’s generic Victoza, the first once-daily liraglutide injectable on the US market.

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

Adalvo and CNX Therapeutics have together claimed the first UK launch of a nitrofurantoin generic, introducing their prolonged-release formulation and revealing plans for further European launches.

Sandoz has announced a $275m settlement to resolve with end payers class action antitrust litigation in the US over historical price-fixing allegations, as well as disclosing that it has made a further provision of $265m linked to the case.

Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country’s National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues.

Indian player Indoco has struck a deal with UK distributor Clarity Pharma that will allow it to target the UK market with the launch of 20 products over the next 18 months.