The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

ANI Pharmaceuticals has recorded its highest-ever quarterly revenue of $73.9m during Q2, following the launch of its cortrophin gel and a substantial growth in generics revenue.

Viatris is committing to earlier EBITDA and free cash flow targets for 2022, although it now expects to lose a chunk of revenues for the full year amid severe and sustained foreign currency exposure.

Following a challenging first half for Hikma, executive chairman and CEO Said Darwazah talks to Generics Bulletin about how the firm is planning to be more active in making deals happen, as well as how it plans to address pressures on its Generics division that led to two consecutive downgrades in guidance this year.

Despite a couple of setbacks during Q2, Amneal has sustained continual growth across its business, particularly in the injectables space.

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

The AAM has criticized the passage of the US Inflation Reduction Act though the country’s Senate, claiming that the legislation’s “flawed framework for government price setting” will chill generic and biosimilar development and will reduce patient access.

Amid ongoing confusion around the US interchangeability designation for biosimilars, Joseph Park and Gillian Woollett of Samsung Bioepis talk to Generics Bulletin about the risks of misinformation, the importance of educational efforts, and how language is shaping certain misunderstandings around biosimilars.

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

ANI Pharmaceuticals has recorded its highest-ever quarterly revenue of $73.9m during Q2, following the launch of its cortrophin gel and a substantial growth in generics revenue.

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

An average price rise of over 1,400% was seen for alendronate 70mg tablets in the UK last month, as average prices for a host of other generics more than doubled.

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.

180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.