Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Italian API and CDMO specialist Olon is expanding its high-potency capabilities at a site in India, at the same time as unveiling plans to invest a further €30m in a domestic biotech hub.

Apotex is to be acquired by SK Capital, the private investment firm has announced. The Canadian generics giant’s new owner has promised to invest in the firm to “support Apotex’s next phase of growth and continued innovation for patient affordability.”

Stada advances its Specialty ambitions by launching the EU’s first authorized treatment for the rare kidney disease immunoglobulin A nephropathy in the form of its modified-release budesonide capsules.

The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.

India’s national list of essential medicines 2022 features 34 additions, including insulin glargine, teneligliptin, lenalidomide, bedaquiline and montelukast, with price control expected to follow on these drugs.

Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.

The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

The US Association for Accessible Medicines’ annual report into generic and biosimilar savings has documented another year of increased cost savings thanks to off-patent drugs, but says some patients are still overpaying for their generic medicines. 

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

With multiple Humira biosimilars slated for launch in the US next year, some simultaneously, a Vizient survey provides some insights into what could be the most important differentiating aspects. Generics Bulletin speaks to Steven Lucio, Vizient senior principal of pharmacy solutions, about the findings.

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Health Canada approves Ryaltris for allergic rhinitis, opening up yet another major market for Glenmark’s branded specialty medicine. Bausch Health will sell the drug in Canada.

Stada advances its Specialty ambitions by launching the EU’s first authorized treatment for the rare kidney disease immunoglobulin A nephropathy in the form of its modified-release budesonide capsules.