After nearly 40 years, Amgen remains among the world’s largest biopharma companies with a market cap of $114 billion. In 2016, Amgen’s portfolio of top sellers
boasted seven blockbuster drugs (classified as $1 billion or
more in annual sales). Of these, five are still growing, Enbrel,
Aranesp, Prolia, Sensipar and Xgeva. Osteoporosis drug Prolia,
has shown the strongest gains (25%) over the last year. However, biosimilar competition in today’s market is fierce and
Amgen’s products are among the prime targets.
Enbrel sales soared 11% in 2016, just shy of $6 billion,
while sales of Neulasta, a treatment for chemotherapy induced neutropenia, were pretty much flat at $4.6 billion due
to increased competition in this space and patent expirations.
Sales of Amgen’s original flagship blockbusters, Epogen and
Neupogen (the industry’s first victim of biosimilar competition), have fallen dramatically in recent years, down a third
Kyprolis, Blincyto and Repatha are Amgen’s fastest growing drugs but they have a way to go to compensate for the
decline of core products.
Despite increased competition and patent expirations, 10 out
of Amgen’s 13 products grew in 2016. Not unlike many of its
competitors, advancing its pipeline assets is essential to maintaining growth. Amgevita and Erenumab look to be the most
promising sources of revenue for the company in the near term.
Safety issues surrounding Evenity and less than impressive
Repatha results are among the company’s most recent road
blocks. Osteoporosis drug Evenity was close to gaining FDA
approval, but a recent study showed an increased risk of heart-related side effects. It’s not likely to be approved this year and
its future is in question. Also, Repatha, a new cholesterol reducing drug, showed positive results in a recent study but not
enough to impress investors or outstrip the competition, and
as a result, it could face tougher payer reimbursement.
In the way of positive news, Amgen submitted a Biologics License Application to the FDA for its new migraine drug
Erenumab, which demonstrated positive Phase III results from
pivotal studies in more than 2,600 patients with episodic and
Amgen and development partner, Novartis, recently expanded their collaboration for erenumab, a fully human monoclonal antibody specifically designed to target and block the
Calcitonin Gene-Related Peptide (CGRP) receptor, believed to
have a critical role in mediating migraine pain. The companies
have agreed to combine capabilities to co-commercialize erenumab in the U.S. Amgen retains exclusive rights in Japan and
Novartis gains exclusive rights in Canada, retaining its existing
rights in rest of the world.
Amgevita, Amgen’s biosimilar to AbbVie’s $16 billion top-seller Humira, was approved by the FDA and the EU, but on-going litigation could significantly delay launch. Amjevita is
the first Humira biosimilar to be approved in the U.S.
AbbVie filed a lawsuit seeking to block Amgen from sell-
ing a copy of the arthritis medicine, and according to AbbVie,
Amgen’s proposed biosimilar would infringe at least 10 pat-
ents, and AbbVie has reserved the right to assert as many as
51 other patents. Unfortunately for Amgen, the trial is not
expected to begin until November 2019, and Amgen is not
alone in its pursuit for a Humira biosimilar. Samsung Bioepsis’
Imraldi was recently recommended for approval by the EMA.
The EMA also recently accepted an application for review from
Sandoz, and Boehringer Ingelheim’s recent Phase III study
confirmed its biosimilar candidate has similar efficacy, safety
and immunogenicity to Humira—just to name a few...
Moreover, with respect to the Sandoz v. Amgen dispute, on
June 12, the U.S. Supreme Court released a highly anticipated
decision relating to patent disputes between the developers of
new biologics and the manufacturers of“biosimilar” copies.
Sandoz received approval from the European Commission
for Erelzi, its biosimilar to Amgen’s Enbrel to treat inflamma-
tory diseases such as rheumatoid arthritis, psoriasis, and pso-
On one issue, Sandoz won. As a result of the court’s rul-
ing, biosimilar companies will generally be able to launch
their products as soon as the data exclusivity on the innovative
product expires. On the second issue, however, the outcome
was a bit murky. Amgen lost the immediate dispute presented
to the Supreme Court, but the litigation is not over, and there
are still key questions to be resolved concerning not only fed-
eral but also state law, namely California.
With respect to innovation efforts, two early stage R&D
investments aim to target cancer. Amgen and Immatics Bio-
technologies entered a research collaboration and exclusive
license agreement to develop next-gen T-cell engaging bispe-
cific immunotherapies targeting multiple cancers. Amgen paid
$30 million upfront and Immatics is eligible to receive more
than $500 million in development, regulatory and commercial
milestones, as well as royalties on sales.
Additionally, Amgen acquired global rights from Boehring-
er Ingelheim for BI 836908 (AMG 420), a bispecific T cell en-
gager (Bi TE) that targets B-cell maturation antigen, a potential
target for multiple myeloma. The drug is currently in Phase I
studies. The companies will work together on clinical develop-
ment, transfer of manufacturing, and global regulatory activity.
Among assets closer to fruition, Amgen will sponsor a clini-
cal trial collaboration and supply agreement with Janssen Biotech
that will evaluate the efficacy and safety of CD38-directed immu-
notherapy Darzalex, in combination with Amgen’s proteasome
inhibitor Kyprolis and dexamethasone, to treat cancer. The first
Phase III study will determine if this combination improves sur-
vival compared to Kyprolis and dexamethasone alone in multiple
myeloma in patients who have received prior therapies.
Also, Amgen and Daiichi Sankyo Co. entered an exclusive
agreement to commercialize nine biosimilars in Japan. The
deal includes several biosimilars in late-stage development,
including biosimilars of Humira, Avastin and Herceptin. Am-
gen is responsible for the development and manufacturing of
the biosimilars and Daiichi Sankyo will file for marketing ap-
proval and be responsible for distribution and commercializa-
tion in Japan.
Despite current challenges, Amgen’s strong foundation as a
biologics pioneer should prevail. Near term assets and strong
revenue streams for top sellers should offset any losses for
flagship products—for now. CP