Generics Bulletin previews the most noteworthy and anticipated events for March 2024.
March brings the expiry of a major biologic patent in Europe, albeit one with relatively limited biosimilar chasers, highlighting to some extent the development gap for such opportunities.
Xolair (omalizumab), an IgG1 monoclonal antibody approved to improve the control of severe persistent asthma caused by an allergy and chronic spontaneous urticaria, runs its patent course this month
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
