Biogen Inc 's

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.