The hotly contested case concerning biosimilar versions of Roche's Herceptin (trastuzumab) witnessed a seesaw shift after a division bench of the Delhi High Court held that the status prevailing prior to a stinging April 25 order against Biocon Ltd. and Mylan NV will continue to operate.
The court, though, is said to have declined to stay the previous order.
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The San Diego biotech’s lead product candidate is an antisense oligonucleotide-based therapy slated to enter Phase III development in the third quarter.
The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Merck is investing $ 1bn in a Delaware facility to produce Keytruda and expand biologics manufacturing amid US tariff concerns.
