Generic Drugs

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.

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.

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.”

 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.

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.

Bangladesh’s Beximco reported double-digit growth both domestically and abroad in its financial first half, while continuing to expand in other international markets. Given its new launches and a COVID-19 vaccine distribution deal, the company remains optimistic about its future performance.

The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

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. 

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With concern over the mpox health emergency continuing to build, the Medicines Patent Pool has offered its services to play a part in the global response.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

With Sagent Pharmaceuticals operating in an increasingly competitive US injectables market, the company has recently been making moves to bolster its position in the wake of its separation last year from its former parent company, Japan’s Nichi Iko. Chief executive Vishy Chebrol talks to Generics Bulletin about the firm’s strategic goals.

Generics Bulletin reviews the latest regulatory events across the world.