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Biogen Inc 's Comment on Competitors and Industry Peers
Competition
Competition in the biotechnology and pharmaceutical industries is intense and
comes from many and varied sources, including specialized biotechnology firms
and large pharmaceutical companies. Many of our competitors are working to develop
products similar to those we are developing or already market and have considerable
experience in undertaking clinical trials and in obtaining regulatory approval
to market pharmaceutical products. Certain of these companies have substantially
greater financial, marketing and research and development resources than we do.
We believe that competition and leadership in the industry is based on managerial
and technological excellence and innovation as well as establishing patent and
other proprietary positions through research and development. The achievement
of a leadership position also depends largely upon our ability to identify and
exploit commercially the products resulting from research and the availability
of adequate financial resources to fund facilities, equipment, personnel, clinical
testing, manufacturing and marketing. Another key aspect of remaining competitive
within the industry is recruiting and retaining qualified scientists and technicians.
We believe that we have been successful in attracting skilled and experienced
scientific personnel.
Competition among products approved for sale may be based, among other things,
on patent position, product efficacy, safety, convenience, reliability, availability
and price. In addition, early entry of a new pharmaceutical product into the market
may have important advantages in gaining product acceptance and market share.
Accordingly, the relative speed with which we can develop products, complete the
testing and approval process and supply commercial quantities of products will
have an important impact on our competitive position.
We may face increased competitive pressures as a result of the emergence of
biosimilars. In the U.S., a number of our marketed products, including AVONEX,
TYSABRI and RITUXAN, are licensed under the Public Health Service Act (PHSA)
as biological products. In March 2010, U.S. healthcare reform legislation amended
the PHSA to authorize the FDA to approve biological products, known as biosimilars
or follow-on biologics, that are shown to be highly similar to previously approved
biological products based upon potentially abbreviated data packages. The approval
pathway for biosimilars does, however, grant a biologics manufacturer a 12 year
period of exclusivity from the date of approval of its biological product before
biosimilar competition can be introduced. Biosimilars legislation has also been
in place in the E.U. since 2003. In December 2012, guidelines issued by the
EMA for approving biosimilars of marketed monoclonal antibody products became
effective. If a biosimilar version of one of our products were approved, it
could reduce our sales of that product.
Additional information about the competition that our marketed products face
is set forth below.
AVONEX, TYSABRI and TECFIDERA
Each of AVONEX, TYSABRI and TECFIDERA competes with the following products:
Along with us, a number of companies are working to develop additional treatments
for MS that may in the future compete with AVONEX, TYSABRI, TECFIDERA or all
of them. For example, a marketing application for LEMTRADA (alemtuzumab) (developed
by Sanofi) has been approved in the E.U. as a treatment for MS in September
2013. In addition, the commercialization of our own products, such as TECFIDERA,
may negatively impact future sales of AVONEX, TYSABRI or both. Further, following
the expected expiration of Teva Pharmaceutical’s patent protection for
COPAXONE (May 2014 for its U.S. patents and in May 2015 for its European patents),
we anticipate that additional companies will introduce similar versions of COPAXONE
that may also create further competition in the MS market.
FAMPYRA
FAMPYRA is indicated as a treatment to improve walking in adult patients with
MS who have walking disability and is the first treatment that addresses this
unmet medical need with demonstrated efficacy in people with all types of MS.
FAMPYRA is currently the only therapy approved to improve walking in patients
with MS, and benefits from exclusivity rights that prohibit generic versions
from being marketed.
FUMADERM
FUMADERM competes with several different types of therapies in the psoriasis
market within Germany, including oral systemics such as methotrexate and cyclosporine.
RITUXAN IN ONCOLOGY
RITUXAN competes with several different types of therapies in the oncology market,
including:
TREANDA (bendamustine HCL) (marketed by Cephalon (Teva Pharmaceuticals)), which
is indicated for CLL and for patients with indolent B-cell NHL that has progressed
within 6 months of treatment with RITUXAN.
ARZERRA (ofatumumab) (marketed by GenMab in collaboration with GlaxoSmithKline),
which is indicated for CLL patients refractory to both alemtuzumab and fludarabine.
We also expect that over time GAZYVA will compete with RITUXAN, TREANDA AND
ARZERRA in the oncology market. In addition, we are aware of other anti-CD20
molecules, including biosimilars, in development that, if successfully developed
and registered, may compete with RITUXAN and GAZYVA in the oncology market.
RITUXAN IN RHEUMATOID ARTHRITIS (RA)
RITUXAN competes with several different types of therapies in the RA market,
including:
Traditional therapies for RA, including disease-modifying anti-rheumatic drugs
such as steroids, methotrexate and cyclosporine, and pain relievers such as
acetaminophen.
TNF inhibitors, such as REMICADE (infliximab) and SIMPONI and SIMPONI ARIA (golimumab)
(marketed by Johnson & Johnson), HUMIRA (adalimumab) (marketed by AbbVie,
Inc.), ENBREL (etanercept) (marketed by Amgen, Inc. and Pfizer) and CIMZIA (certolizumab
pegol) (marketed by UCB, S.A.).
ORENCIA (abatacept) (marketed by Bristol-Myers Squibb Company).
ACTEMRA (tocilizumab) (marketed by the Roche Group).
XELJANZ (tofacitinib) (marketed by Pfizer).
We are also aware of other products, including biosimilars, in development that,
if successfully developed and registered, may compete with RITUXAN in the RA
market.
Overall company Market Share Q4 2020 |
*Market share calculated with total revenue.
BIIB's vs. Competition, Data
(Revenue and Income for Trailing 12 Months, in Millions of $, except Employees)
| COMPANY NAME |
MARKET CAP |
REVENUES |
INCOME |
EMPLOYEES |
| Biogen Inc |
13,445 |
41,056 |
4,061 |
7,550 |
| Allergan plc |
16,096 |
64,063 |
-2,479 |
10,500 |
| MEDIMMUNE, INC. |
0 |
0 |
0 |
0 |
| Pfizer Inc |
41,908 |
194,467 |
9,652 |
78,300 |
| SCHERING-PLOUGH CORPORATION |
0 |
0 |
0 |
0 |
| Wyeth |
0 |
0 |
0 |
0 |
| Amgen Inc |
32,341 |
131,005 |
7,264 |
17,900 |
| Covidien Plc |
10,880 |
0 |
1,605 |
39,500 |
| Bristol Myers Squibb Co |
42,518 |
142,778 |
-8,995 |
25,000 |
| Merck and Co Inc |
47,994 |
186,023 |
7,082 |
70,000 |
| Abbott Laboratories |
34,608 |
213,503 |
4,495 |
77,000 |
| Johnson and Johnson |
82,584 |
418,201 |
14,714 |
126,500 |
| Abbvie inc |
45,804 |
190,709 |
4,622 |
26,000 |
| Celgene Corp |
16,982 |
78,961 |
1,834 |
6,012 |
| Baxter International Inc |
11,673 |
0 |
1,110 |
0 |
| SUBTOTAL |
396,833 |
1,660,767 |
44,965 |
484,262 |
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