South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use.
A biosimilar copy of Amgen's Enbrel made by South Korea's Samsung Bioepis could be recommended for approval as soon as Friday (Nov. 20) for use in Europe, according to a report by Reuters. The move comes just days after the company said its Brenzys (SB4) biosimilar and others showed comparable safety and efficacy to the original products.
Novartis is moving toward the U.S. market with a biosimilar of Amgen's Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.
Amgen's knockoff of AbbVie's top-selling Humira measured up to its reference product in a Phase III trial, clearing the way for the Big Biotech as it waits for the blockbuster injection to lose patent protection next year.
Call it a biopharma plant in a box--62 boxes actually. That is how many containers were shipped from a GE production facility to China to build GE's first prefab biologics plant for JHL Biotech, a company founded by U.S. biotech veterans working on biosimilars.
Biomab Brilliant has paid $25.8 million to India's Cipla for 100% of Biomab Holding in a transaction that sees both firms carve out a new direction in the aim to produce biosimilar drugs, a path many drug firms in both countries are busy at work on.
India's Dr Reddy's Laboratories is looking to increase sales of biosimilars in emerging markets and plans to launch products in Russia as well as licensing deals in Southeast Asia, its chief operating officer told an earnings call, according to a Reuters report.
Amgen is steeling itself against biosimilar competition to some of its top meds, with a biosimilar of its best-selling cancer drug Neupogen hitting the market in September and threatening to take a bite out of sales. But the company hasn't hit the eye of the storm just yet, as older products delivered Street-beating sales in the third quarter and new drugs showed potential in helping Amgen shore up its defenses.
India's ability to copy chemical-based drugs has been the foundation of the country's $15 billion pharmaceuticals industry, but its inability to produce more complex biological drugs at scale means regions like South Korea, the United States and Europe are already well ahead in the race, according to a report by the Economic Times.
As the world's best-selling drug, AbbVie's Humira has a biosimilar target painted on its back--and Baxalta is the latest to take aim.