Pfizer is looking for the Biden administration’s co-operation to address the policy issue of affordability and access to biosimilars. In the first quarter, the company’s biosimilars segment grew by 84% on the back of new launches, especially in the US where biosimilars sales nearly doubled. 

Hyloris is on a roll with licensing deals for its Maxigesic IV non-opioid pain treatment, with an extension of its existing agreement with Pharma Bavaria to cover South American territories coming hot on the heels of recent developments in the US and Europe.

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Despite turnover dropping by over a fifth in its financial third quarter, Lannett says it is optimistic that respiratory generics and insulins will offer the firm “durable” opportunities in future. The company has also just reorganized its finances to extend its debt maturity by four years, pushing it back past some of its key launches.

Laurus Labs has reported a 70% jump in annual revenues after what the company described as an “extraordinary year.” The firm has decided to expand its current capacities to meet the increased demand for third-party API sales and is looking to file eight to ten ANDAs next year as it sees “many long-term opportunities in the US generics space.”

Samsung Bioepis has been tight-lipped on the potential to win approval for its SB11 biosimilar ranibizumab product this year, though new similarity data is a further positive omen for the Korea-based biosimilar player.

Legislation that could thin the crowded generic market clears first parliamentary hurdle as brand and generic firms alike react to the recent generic quality issue raised by recent manufacturing incidences at some South Korean pharma firms.

Alberta has become the latest Canadian province to expand its biosimilar switching program to cover adalimumab biosimilars to Humira.

The ideas could potentially address sponsor concerns about the effects of slow reviews.

Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.

The UK is putting itself in a position to play a leading role in global biosimilars regulation, thanks to a proposed new registration pathway that will not require comparative efficacy data, delegates to a Westminster Health Forum online conference heard earlier today.

Draft US legislation that would seek to encourage biosimilar adoption by temporarily boosting reimbursement has received the backing of the AAM.

Teva said it was once again at the mercy of the COVID-19 pandemic as it forecasted an extended if not indefinite wait for both criminal and civil proceedings over alleged generic drug price fixing in the US to move to trial.

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Legislation that could thin the crowded generic market clears first parliamentary hurdle as brand and generic firms alike react to the recent generic quality issue raised by recent manufacturing incidences at some South Korean pharma firms.

Pfizer is looking for the Biden administration’s co-operation to address the policy issue of affordability and access to biosimilars. In the first quarter, the company’s biosimilars segment grew by 84% on the back of new launches, especially in the US where biosimilars sales nearly doubled. 

Australia’s government has agreed to extend a successful biosimilar education initiative led by the local GBMA industry association.

Alberta has become the latest Canadian province to expand its biosimilar switching program to cover adalimumab biosimilars to Humira.

Hyloris is on a roll with licensing deals for its Maxigesic IV non-opioid pain treatment, with an extension of its existing agreement with Pharma Bavaria to cover South American territories coming hot on the heels of recent developments in the US and Europe.

Hyloris has secured Hikma as its US marketing partner for Maxigesic IV. The deal gives Hyloris access to Hikma’s presence in complex, injectable hospital products while aligning with Hikma’s push into differentiated treatments.

Recent Canadian, European and US endorsements of Mithra’s estetrol-based Estelle novel oral contraceptive mark a “turning point” for the Belgian firm, which has also seen success with its Myring generic rival to NuvaRing for which it expects to see further launches this year.