Biosimilar Development Updates

Below are some recent highlights of biosimilar news:

On August 20th, two companies announced that they had launched competing biosimilars of Eli Lilly’s FORSTEO (teriparatide) in Europe.  First, Gedeon Richter announced that it launched TERROSA in Europe after it received approval from the European Commission.  According to the announcement, the launch of TERROSA last month directly followed the expiry of patent protection of the reference product FORSTEO.  Second, Stada announced that it launched MOVYMIA.  According to the announcement, Stada will be gradually launching MOVYMIA in 24 countries.  CEO Peter Goldschmidt stated that “[t]he launch of MOVYMIA is another important expansion of our biosimilar portfolio in Europe.”  Both biosimilars, and the reference product, are indicated for the treatment of osteoporosis.

On August 21st, Nippon Kayaku Co., Ltd. (NK) announced that it obtained approval for its 60mg and 150mg dosages of Trastuzumab BS NK, its biosimilar to HERCEPTIN (trastuzumab), for breast cancer with HER2 overexpression.  Nippon has been marketing the product under other indications and dosages since August 2018.

On August 31st, Biocon announced that the FDA had issued a second complete response letter (CRL) to Mylan regarding Biocon’s facilities in Malaysia, where it intends to manufacture its biosimilar to LANTUS (insulin glargine).  According to the announcement, “the CRL did not identify any outstanding scientific issues” and that Biocon is not expecting the CRL to have any impact “on the commercial launch timing of [its] Insulin Glargine in the U.S.”

On September 6th, Novo Nordisk announced that it is expanding its affordability options for its follow-on insulin products NOVOLOG and NOVOLOG MIX starting on January 2, 2020.  According to the announcement, the products “will be priced at a 50 percent discount compared to the current list price of the branded versions.”

On September 9th, Samsung Bioepis announced that BRENZYS, its biosimilar to ENBREL (etanercept), became available in Brazil through Brazil’s public health system, Sistema Único de Saúde (“SUS”).  In December 2017, BRENZYS was approved by Brazil’s health regulatory agency for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.  According to the announcement, over 75% of patients in Brazil rely on SUS for health care coverage, and the agreement with SUS will allow Samsung Bioepis to supply BRENZYS for 10 years.

On September 11th, Teva Canada announced that Health Canada granted a Notice of Compliance for HERZUMA, its biosimilar to HERCEPTIN (trastuzumab) for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer.  According to the announcement, Health Canada’s issuance of a Notice of Compliance demonstrates that “HERZUMA and HERCEPTIN are highly similar and there were no clinically meaningful differences in purity, potency and safety between them for the three approved indications.”