瑞信-全球-制药行业-全球制药业：跟上生物仿制药的步伐-421-40页.pdf
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April 21, 2019
Global Pharmaceuticals
Keeping Up With the Biosimilars (April 2019)
RESEARCH ANALYSTS
Vamil Divan, MD
(1) 212-538-5394
vamil.divan@credit-suisse.com
Uy Ear
(1) 212-325-1729
uy.ear@credit-suisse.com
Michael V. Morabito, Ph.D.
(1) 212-325-7298
michael.morabito@credit-suisse.com
Inanc Caner
(1) 212-325-5051
inanc.caner@credit-suisse.com
European Pharma Team
(44) 207-888-0304
creditsuisse.pharmateam@credit-
suisse.com
Ray Kim
(82) 2-3707-3776
ray.kim@credit-suisse.com
DISCLOSURE APPENDIX AT THE BACK OF THIS REPORT CONTAINS IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS, LEGAL ENTITY DISCLOSURE AND
THE STATUS OF NON-US ANALYSTS. US Disclosure: Credit Suisse does and seeks to do business with companies covered in its research reports. As a result, investors should be
aware that the Firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment
decision.
Updating Investors on Progress of Biosimilars: We are publishing the latest version of
our Biosimilars Tracker, where we provide a more comprehensive look at the latest
developments in the biosimilar market, including updates on how the regulatory, legal and
payer landscape may be evolving to help create a more vibrant biosimilar market, including
in the US.
Impact of Biosimilar Humira Most Closely Watched in the EU: As the world’s best-
selling product, there has been close scrutiny on the erosion of Humira since the entry of
biosimilar versions of the drug in the EU in October. We will get more insights on this
dynamic on ABBV’s 1Q19 earnings call on Apr 25, but they have already acknowledged
they expect a ~30% decline in total ex-US Humira sales in 2019. We look to see if the
company further adjusts its 2019 expectations on the call and, perhaps more importantly,
if they provide greater color on the rate of erosion they expect in 2020 and beyond.
Multiple Pushes and Pulls as Biosimilar Market Evolves: In recent months, we have
seen several additional biosimilar approvals, including another biosimilar Humira in the EU
and multiple biosimilar versions of Roche’s Herceptin. The FDA has also released a series
of guidances and revised guidances to help provide more clarity to biosimilar developers on
what the agency is looking for to approve biosimilar and potentially interchangeable
products. However, we have also seen continued commercial challenges with the rollout of
some biosimilars in the US market, most notably biosimilar versions of Remicade which
have only obtained about 8% of infliximab molecule share despite multiple biosimilar
versions of Remicade being on the US market for nearly two years now.
Pfizer, Novartis Best Positioned, While AbbVie, Roche Most at Risk: Pfizer and
Novartis face potential sales erosion from biosimilars in the coming years, but they are also
developing their own biosimilars that we expect to help offset some of that risk. On the
other side of the spectrum, we see AbbVie and Roche as the two companies most
exposed to biosimilar risk given the threat to their blockbusters Humira (for AbbVie) and
Rituxan, Herceptin and Avastin (for Roche).
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