The FDA is scheduled to announce its decision on the subcutaneous (SC) formulation of Herceptin for the treatment of patients with HER2-positive breast cancer this quarter (Q1, 2019).Roche’s Herceptin is a co-formulation with Halozyme Therapeutics Inc.’s (HALO) proprietary recombinant human hyaluronidase enzyme (ENHANZE technology).Halozyme's ENHANZE drug-delivery technology has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten the time for drug administration.Annual sales of Herceptin in 2018 were 6.98 billion Swiss francs, up 1% over the prior year. The FDA has approved three biosimilar versions of Herceptin - Samsung Bioepis' Ontruzant; Mylan/Biocon’s Ogivri; and Celltrion/Teva’s Herzuma. No Herceptin biosimilar has been launched in the U.S. to-date. The patent protection of Herceptin in the U.S. is expected to expire in mid-June 2019.RHHBY.OB closed Tuesday’s trading at $34.81, up 0.59%.