Lotus Pharmaceuticals Co (美時化學製藥) yesterday launched the world’s first generic equivalent of the oncology drug Revlimid (lenalidomide) in a number of central and east European markets.
The company’s bioequivalent drug has been approved in Romania, Croatia, Bulgaria and the Baltic states, and it is eyeing a global launch this year.
Revlimid treats multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma, and is considered to be the single biggest-selling oncology drug, with approximately US$9.8 billion in global sales, the company said.
The product is marketed in the form of 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg capsules, it said, adding that the new generic drug represents a milestone at its production plant in Nantou County.
The company last month also added Evista (raloxifene), which is used in the prevention and treatment of osteoporosis, to its portfolio of branded products via a US$22 million acquisition deal with Takeda Pharmaceutical Co.
Lotus is to take over all of the product’s intellectual property and existing businesses in seven Asia-Pacific markets, including Hong Kong, Macau and Thailand, from April, while a formal closing of the deal is expected early next year.
In related news, TaiMed Biologics Inc (中裕新藥) yesterday said that the European Medicines Agency (EMA) has completed onsite inspections of its manufacturing partner as the company nears the launch of Trogarzo, its HIV/AIDS drug in the single market.
TaiMed said that EMA inspectors found no critical deficiencies at the facilities at China’s WuXi AppTed (藥明康德), its manufacturing partner.
Trogarzo has been granted accelerated assessment procedure by the EMA and has been under review since September last year.
The company expects the drug to be approved before the end of next year.
Meanwhile, the company’s NT$1 billion protein manufacturing plant in Hsinchu County’s Jhubei City (竹北) is expected to begin production next year, helping it reduce its reliance on costly contract manufacturing and diversify its supply sources.
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