Shilpa Medicare’s plan for trials of an Eylea biosimilar shows the company’s ambition to leapfrog to a biosimilars-led growth strategy, one that Indian majors like Cipla and Lupin pivoted to post a successful generics program. However, the path isn’t going to be easy and Biocon/Viatris, Samsung Biologics are ahead

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.