The Emergence of Oncology Biosimilars
Reference Code: GDHC1192EI
Publication Date: January 2017
The Emergence of Oncology Biosimilars
The coming year will be a tumultuous one for the
pharmaceutical industry as the major companies continue to struggle with the
dreaded patent cliff—an extended period where a significant proportion of
branded drugs will lose patent protection. During this period, affected drugs
will become vulnerable to competition from copycats. In particular, in 2017 the
hugely successful class of complex biologic oncology drugs, which include
monoclonal antibodies, will for the first time become vulnerable to competition
from copy biologics, known as biosimilars, in Western markets.
Biosimilars are a rapidly growing sector of the
industry. Despite a number of biosimilars already approved in the EU and US
markets, this sector is still in its infancy, and the rules that govern them
are continually evolving. Furthermore, while biosimilars have been available in
the EU for other therapy areas since 2006, uptake has been variable and the
threat of oncology biosimilars has been the cause of significant anxiety for
major pharmaceutical companies, like Roche. Key opinion leaders in medical
oncology have expressed caution over the acceptance of biosimilars in place of
the originator or branded products, stating that more data are needed to
convince them that biosimilars are equally effective. However, in the EU, this
decision may be taken out of doctors’ hands, if payers insist that biosimilars
are used for the lower cost. The competitive threat posed by oncology
biosimilars is an unknown entity, and companies will be watching closely to see
how the market reacts to the launch of these new biosimilars this year.
The next 12 months will mark an important milestone in
the evolution of the pharmaceutical industry. The launch of biosimilars to
rituximab and trastuzumab will help to define this sector. The success or
failure of these agents will be the yardstick for other pharmaceutical
companies and will inform the future responses of originator companies that
expect to face biosimilar competition to their cancer drugs.
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