Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.

The impact of drug shortages in Japan, including of essential products, is being considered as part of government-level discussions to consider the appropriateness of the current reimbursement pricing system. Amid rising production costs and wider global challenges, some experts in the industry are now asking for price increases.

The impact of drug shortages in Japan, including of essential products, is being considered as part of government-level discussions to consider the appropriateness of the current reimbursement pricing system. Amid rising production costs and wider global challenges, some experts in the industry are now asking for price increases.