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