MYLAN LABORATORIES LIMITED

Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements.

Viatris plans to file its fast-acting meloxicam formulation for FDA approval this year, targeting acute pain management based on positive Phase III data in post-surgical settings.

A new sustained-release formulation of flucytosine for cryptococcal meningitis has entered Phase II trials in Malawi and Tanzania, simplifying dosing from four times to twice daily and improving administration options.

The Patent Trial and Appeal Board (PTAB) has issued multiple final written decisions finding Regeneron's aflibercept-dosing patents for EYLEA unpatentable, with Regeneron voluntarily dismissing several Federal Circuit appeals.

The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption.

• The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis and to be marketed by Merck & Co in the United States. • The biosimilar is approved for multiple indications including HER2-positive breast cancer and metastatic gastric cancer, offering a potentially more affordable treatment option. • This marks Samsung Bioepis' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva and Mylan in the Herceptin biosimilar market.

The FDA has approved Mylan's glatiramer acetate injections in two dosage forms (40 mg/mL three-times-weekly and 20 mg/mL once-daily) as therapeutically equivalent alternatives to Teva's Copaxone for relapsing forms of multiple sclerosis.