Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.
Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.
The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Biocon Biologics has announced the latest milestone in its integration of former partner Viatris’s biosimilars business, completing the move in the US and Canada “ahead of schedule.”
To tackle the increase in demand for remdesivir in India amidst the second wave of COVID-19, Gilead Sciences is helping local licensees to scale up production of the product, including by providing API supplies. The company is also donating at least 450,000 vials of the Veklury brand “to help address the immediate needs of Indian patients.”
While Celltrion has delivered an unimpressive first quarter of 2021, the company has pointed to plans to launch high-margin products in new markets. The Korean firm said that it was looking to launch its subcutaneous Remsima SC infliximab formulation in Canada and Australia in 2021, while it is also aiming to launch its Yuflyma (adalimumab) in more than 70% of the EU adalimumab market.
Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.
Formycon and partner Bioeq have offered further details on timing for the submission of their FYB201 proposed ranibizumab biosimilar version of Lucentis in Europe, the US and elsewhere.
To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022.
Teva has launched the first US generic version of Absorica (isotretinoin), expanding its dermatological portfolio. The company has also launched generic erythromycin tablets in the US. Meanwhile, in its recent environmental, social and governance progress report, Teva has launched a plan to increase access to medicines globally by 2025.
After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024.
Hikma CEO Siggi Olafsson has outlined the potential future opportunity that the firm sees in the US biosimilars market, in the second part of an exclusive interview with Generics Bulletin.
Shanghai Henlius Biotech is planning to move forward with wet AMD trials for its bevacizumab biosimilar rival to Avastin following a nod from the US FDA.