Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

A strong tailwind from antipsychotic drug Vraylar helped Hungary’s Gedeon Richter to post a 40% leap in 2019 net profit. Analysts see more upside ahead for eastern Europe’s largest drugmaker.

Sandoz US president Carol Lynch talked to Scrip about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo.

Glenmark can sell its partnered generic rival to GSK’s Seretide Accuhaler dry powder inhaler in certain European markets following a settlement with the UK company. The Indian firm has also shelved divestment plans for its API business, at least for now.

Sawai’s sales increased on the back of a good performance from recently-launched products in the first nine months of its financial year. However, given the competitive environment the Japanese company is continuing to stick to its full-year forecasts.

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.

As part of its response to the coronavirus outbreak, Medicines for Europe has set out a series of policy recommendations that it says could help to mitigate the risks of COVID-19.

An AAM-sponsored study by researcher Avalere Health has concluded that Medicare Part D policy changes have led to generics being placed on non-generic tiers 53% of the time in 2020, with generics placed on the ‘preferred generic’ Tier 1 just 10% of the time.

Regulatory processes need to be optimized and must reflect increasing globalization, heard delegates to Medicines for Europe’s 2020 Regulatory & Scientific Affairs conference. Digital technologies are part of the solution.

Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.

Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Sandoz US president Carol Lynch talked to Scrip about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo.

Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Belgian off-patent industry association Medaxes has set out its aspirations for a new biosimilars taskforce that has been set up by local health insurance body INAMI. Data cited by the industry body shows that biosimilar penetration in Belgium is still lagging behind that of its European neighbors.

A strong tailwind from antipsychotic drug Vraylar helped Hungary’s Gedeon Richter to post a 40% leap in 2019 net profit. Analysts see more upside ahead for eastern Europe’s largest drugmaker.

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.

Quarterly global Basaglar sales rose above $300m for the first time in the fourth quarter of 2019, with full-year turnover pushing the insulin glargine hybrid well into blockbuster territory.

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the format of the content or the method in which you receive and access Generics Bulletin, or if you love it how it is, now is the time to have your voice heard.