HPE HPE Fresenius Kabi handbook - Page 22

TABLE 1 Authorised biosimilars (to October 2018) (Continued) Product name INN/active substance Therapeutic area Marketing authorisation holder Marketing authorisation date Hefiya Adalimumab Ankylosing spondylitis, hidradenitis suppurativa, juvenile rheumatoid arthritis, psoriasis, uveitis Sandoz 26/07/2018 Hyrimoz Adalimumab Ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, juvenile rheumatoid arthritis, papulosquamous skin disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis Sandoz 26/07/2018 Trazimera Trastuzumab Stomach neoplasms Breast neoplasms Pfizer 26/07/2018 Hulio Adalimumab Ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis Mylan/Fujifilm Kyowa Kirin Biologics CHMP positive opinion 26/07/2018 Pelgraz Pegfilgrastim Neutropenia Accord Healthcare Committee for Medicinal Products for Human Use (CHMP) positive opinion 26/07/2018 Udenyca Pegfilgrastrim Neutropenia ERA Consulting CHMP positive opinion 26/07/2018 Ziextenzo Pegfilgrastrim Neutropenia Sandoz CHMP positive opinion 20/09/2018 Pelmeg Pegfilgrastrim Neutropenia Cinfa Biotech CHMP positive opinion 20/09/2018 Fulphila Pegfilgrastrim Neutropenia Mylan CHMP positive opinion 20/09/2018 referencing to the high-selling biologics trastuzumab, adalimumab, and pegfilgrastim were approved and entered the market. Up to ten adalimumab biosimilars are expected to launch over the next year. The EMA publishes an EPAR for every medicine granted marketing authorisation via the centralised mechanism. Each EPAR represents a highly valuable and useful information resource for health care professionals who are interested in in-depth information on a particular medicine. In addition, the EMA and the European Commission have published an information guide for healthcare professionals to provide reference information on the science and regulation of biosimilar medicines. 5 However, the EMA’s evaluation of biosimilars does not include recommendations on interchangeability. Automatic interchange of biosimilars at the pharmacy level is a national prerogative and regulations differ throughout the EU. Bioidentical products Some of the authorised products are based on the 22 | 2019 | hospitalpharmacyeurope.com same regulatory dossier (same date of authorisation) and are manufactured in the same cell line using the same manufacturing process. These so-called ‘bioidenticals’ are the same (not similar) products but carry different brand names and are marketed by different manufacturers. In fact, substitution of bioidenticals at the pharmacy level is allowed. The identification of bioidenticals is not easily possible for physicians and pharmacists and differing regulations for the substitution of biosimilars and bioidenticals make it even more complex. Additional labelling might be useful and considered by the health authorities. Biosimilars in the future There are hundreds of biologics on the market today and most of the innovative medicinal products contain proteinaceous active substances. Additional top sellers of the mAb class will lose patent protection relatively soon (for example, ranibizumab, aflibercept) and further in the future