Eagle Pharmaceuticals has received approval for a new indication in Japan for its Treakisym (bendamustine) used to diffuse large B-cell lymphoma. The company is looking to expand as it expects the new indication to generate an opportunity worth up to $25m.

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.

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. 

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.”

Bangladesh’s Beximco has reported growth in export sales on the back of the company’s expansion into new international markets. The company delivered strong financial results overall for the third quarter of fiscal 2021, including double-digit growth on the domestic front. 

Former senior FDA official Eva Temkin has criticized the FDA’s silence on the development of biosimilars and interchangeable products in its recent COVID-19 guidance, suggesting that the agency’s stance on 180-day exclusivity for small-molecule generics could be extended to interchangeability exclusivity for biosimilars, while also pointing out that key questions around generic exclusivity are left unanswered