Concerns over the impact of the proposed US BIOSECURE Act on the CRO and CDMO segments linger despite proponent Mike Gallagher’s plan to leave Congress soon. Which global manufacturers could gain, what determines a shift away from Chinese companies and how imminent is this? Scrip brings insights from industry feedback and other sources.

In 2024, Sun Pharma’s ADC candidate is expected to be in human trials, while CDMOs like Piramal Pharma Solutions and Aurigene are to operationalize significant new capacities. But can India compensate for a late start on the ADC journey by tapping low development costs and favorable policies, or is it too little with China far ahead in the race?

CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.

The damage at one of Pfizer’s largest injectables facilities could lead to gains for a few Indian companies, analysts feel. However, regulatory risks, litigation pay-outs and other challenges will slow growth for domestic firms and Indian units of multinationals like Abbott and Pfizer in FY24, says rating agency ICRA as Q1 results begin coming in