Indian firms are getting their act together in areas like cell and gene therapy, with Dr Reddy’s aiming big and readying a facility alongside an alliance with a Chinese firm for a CAR-T therapy. The company is also doubling down in contract development and manufacturing, with an eye on opportunities in biologics.

Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.

Samsung Bioepis has reported positive Phase III data for its SB12 proposed eculizumab biosimilar to Soliris, with the product showing equivalence in efficacy, safety, PK, PD and immunogenicity.

Education for healthcare professionals and real-world evidence will be important factors in building trust in Byooviz, Samsung Bioepis and Biogen have told Generics Bulletin, acknowledging it will “take some time” for ophthalmologists to grow more comfortable prescribing biosimilars.