Hikma has set out its expectations for a “gradual ramp-up” of the 503B sterile injectable compounding business that it has launched in the US this month, with CEO Siggi Olafsson explaining in detail the strategic rationale for the new business.

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Playing in biosimilars is essential for firms that want to lead in the sterile injectables space, Hikma CEO Siggi Olafsson commented as he discussed how the firm’s injectables business was expected to evolve over the coming years.

Almost 30 generics firms based across 11 countries have signed up to agreements with the Medicines Patent Pool to facilitate the supply of oral COVID-19 treatment molnupiravir to 105 low- and-middle-income countries. The move follows an agreement signed in October by the MPP with Merck.