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The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta® (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of...

Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

US President Biden signed an executive order aimed at promoting competition in the US economy. The order directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, and encourages the FTC to ban ‘pay for delay’ agreements...

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing St...

Opthea announced the FDA has granted fast track designation for OPT-302 (VEGF-C/-D ‘trap’ inhibitor). OPT-302 (a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3)) is intended to treat neovascular (wet) age-related macular degeneration in combination w...

India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.

The Government of Quebec released the details of its biosimilars switching program. Under the new program, patients will continue to be reimbursed for biologics for ongoing treatment until 13 April 2022. After this date, patients will only be reimbursed for biologics for wh...

Merck announced that the FDA has approved an expanded label for Keytruda® (pembrolizumab). Keytruda® is now also approved for the treatment of patients with recurrent of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radia...