FDA Approves GARZULYS — Meitheal Pharmaceuticals Inc.

Meitheal Pharmaceuticals Inc. announced Tuesday that the FDA has granted approval for the first generic version of GARZULYS (insulin aspart), a fast-acting subcutaneous product previously held exclusively by Sanofi. The landmark approval sets the stage for significant market volatility in the fast-acting insulin segment, likely driving down biologic biosimilar pricing and intensifying competitive pressure on existing brands.