CHMP Issues Positive Opinions on Biosimilar Trastuzumab, Adalimumab

Samsung Bioepis’ trastuzumab biosimilar, SB3, referenced on Roche’s Herceptin, has been recommended for approval by the European Medicines Agency (EMA). The drug received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. The biosimilar’s approval will now be referred to the European Commission, which will make a final determination on whether to grant a marketing authorization to Samsung Bioepis for the drug.

Christopher Hansung Ko, president and CEO of Samsung Bioepis, said, “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars.”

Samsung’s product, which the company plans to sell under the name Ontruzant and which will be marketed by MSD (known as Merck in the United States), is poised to become the first biosimilar trastuzumab available in the European marketplace. The reference Herceptin, approved in the European Union in 2000, is among the top-selling drugs in the global marketplace, having earned $6.75 billion in sales in 2016, and has remained unchallenged by biosimilar competition in Europe.

CHMP also issued a positive opinion for Boehringer Ingelheim’s (BI) adalimumab biosimilar for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, axial spondyloarthritis, chronic plaque psoriasis, hidradenitis suppurativa, and panuveitis. BI plans to market the drug under the name Cyltezo.

Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at BI, said, “The recommendation by the CHMP for Cyltezo is an important milestone for Boehringer Ingelheim, bringing us one step closer to providing our first biosimilar to healthcare providers and patients. Chronic inflammatory diseases can be incredibly debilitating and we are delighted that Cyltezo has the potential to improve the lives of many of these patients.”

BI’s biosimilar was approved by the FDA in August, though ongoing patent litigation with reference adalimumab (Humira) manufacturer AbbVie has made it unclear when the biosimilar could be made available for use.

BI has signaled that it intends to seek a US designation of interchangeability with the reference drug, which earned AbbVie $16.08 billion in global sales in 2016. BI has begun to enroll patients in the first study to demonstrate interchangability of an adalimumab biosimilar with Humira. FDA guidance holds that interchangeable status will only be granted if the risk, in terms of safety or diminished efficacy of switching between the reference product and the biosimilar, is not greater than the risk of using the reference product without a switch. The agency also says that it expects manufacturers seeking interchangeable status to include data from switching studies, conducted in sensitive populations, that include at least 3 switches.