The merger between Mylan and Pfizer’s Upjohn unit finally concluded on 16 November 2020, giving Viatris the go ahead for business. The newly-established company has announced receiving tentative approval for its 10mg pediatric dolutegravir tablets from the FDA under the PEPFAR program. 

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

Alvotech has struck a major deal with Yangtze River Pharmaceutical that will allow eight of the biosimilars developer’s products to be commercialized in China.

Krka’s bottom line continues to be stronger than usual, driven by a hike in sales and leaner cost base. Looking to 2021, however, management brought investors back down to earth.

Pfizer’s Greenstone and Sanofi’s Winthrop have together founded a US industry body to represent authorized generics, drawing a distinction between these products and traditional generics.

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

Mooted some time ago, the Medicare Part D Drug Rebate Rule and the Medicare Part B Most-Favored-Nation Model have now been finalized by US President Donald Trump. But US off-patent body the Association for Accessible Medicines feels “further action is necessary.”

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.

Samsung Bioepis last week received a second positive opinion recommending granting a pan-European marketing authorization for a biosimilar bevacizumab product. The Korean firm spoke to Generics Bulletin detailing the rationale.

Samsung Bioepis is lining up two biosimilar bevacizumab products in the EU, after the EMA’s CHMP recommended the company’s Onbevzi product months after approval for Aybintio.

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

Pfizer’s efforts to circumvent two US patents shielding Par’s Adrenalin (epinephrine) have again ended in failure, following a ruling by the US Court of Appeals for the Federal Circuit.

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

After a strong first quarter, Japan’s Towa Pharmaceuticals saw stability in its domestic revenues but a drop in revenues from its overseas business in its financial second quarter. After launching a series of molecules in June 2020, the company has lined up 10 launches for December 2020 as well. 

Outstanding leaders in the off-patent industry have shared their thoughts on leadership priorities in an exclusive roundtable discussion being shown later today, ahead of the Global Generics & Biosimilars Awards 2020 which will be broadcast tomorrow, 3 November.

To boost the technology used in its digihaler family of inhalers, Teva has partnered with Amazon Web Services and Onica, a Rackspace Technology company. With this collaboration, Teva aims to protect patients’ information and ensure data security.

Catalent has announced the launch of a new technology, OptiGel DR, for the formulation and manufacture of delayed/enteric release softgels, offering advantages such as potentially enhancing bioavailability and reducing gastric reflux effects.