Pursuing Medical Breakthroughs

 

 

Our portfolio of therapies aims to address humanity’s most complex and difficult health challenges. We continue to advance scientific innovation that takes us deep into the body’s nervous system, striving to deliver new treatments with the potential to transform care for patients.

Multiple Sclerosis (MS) is the foundation of our multi-franchise portfolio. In fact, as of April 2020, our therapies treated approximately 34 percent of all MS patients worldwide. In 2019 the U.S. Food and Drug Administration approved VUMERITY® (diroximel fumarate), bringing a new therapy to patients with relapsing MS.


We also continued the expansion of SPINRAZA® (nusinersen) for the treatment of spinal muscular atrophy (SMA). By the end of 2019, SPINRAZA was approved in over 50 countries, with formal reimbursement in over 40 countries, including China.

 

 


 

 

Sharing Our Progress

At the 71st annual meeting of the American Academy of Neurology (AAN), we built on our over twenty-years of expertise in MS research and development, with presentations on neurodegenerative diseases from our portfolio of medicines and investigational programs.


In addition to data supporting our established MS therapies – TECFIDERA® (dimethyl fumarate) and TYSABRI® (natalizumab)  – our AAN presentations included results from a clinical investigation of a potential MS biomarker that could help standardize disease monitoring and inform future treatment decisions. While earlier data demonstrated the clinical relevance of the serum neurofilament light chain (sNfL) levels to predict disease severity and monitor treatment response in MS patients, new findings from the ASCEND study further support the potential clinical relevance of sNfL levels.

 

 

 

 

We also presented insights about MS PATHS, our Learning Health System, which generates high-quality data to inform future approaches to patient care. With MS PATHS, researchers can evaluate common and disruptive MS symptoms, such as cognitive changes, to help drive more evidence-based, personalized treatment decisions. Collaborating with 10 leading MS centers in the U.S. and Europe, researchers have collected data from more than 17,000 people with MS to date.


At the annual conference of the European Committee for Treatment and Research in MS (ECTRIMS), we showcased our commitment to improve the care of patients with MS across the treatment spectrum. Data highlighted the benefits of TYSABRI in treating early MS to achieve NEDA (no evidence of disease activity) and improving disability and cognition. Data analysis from the TYSABRI Observational Program demonstrated the effectiveness of extended interval dosing (EID, every six weeks) compared to the approved dosing of every four weeks. And real-world data confirmed that exposure to interferon beta treatment, including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (Interferon beta-1a), is not expected to impact pregnancy or infant outcomes. This data was leveraged for a class-wide label update in the E.U. for interferons, allowing for PLEGRIDY® (peginterferon beta-1a) and AVONEX® (Interferon beta-1a) to be used during pregnancy and breastfeeding in women with relapsing multiple sclerosis. Lastly, we were excited to announce the first enrolled patient in NOVA a global Phase 3b study evaluating the efficacy and safety of extended interval dosing (EID, every six weeks) compared to standard interval dosing for TYSABRI in approximately 480 patients with relapsing MS.

 

 

Leading the way in biosimilars

Biogen is one of only a handful of companies with the market-leading manufacturing capabilities and deep scientific expertise needed to produce biosimilars of advanced biologics. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s approved biological product. They offer cost savings and promote sustainable access to therapies.

 

 

 

 

More than 200,000 patients in Europe have been treated with one of our anti-tumor necrosis factor (anti-TNF) biosimilars. We estimate that our anti-TNF biosimilars have contributed healthcare savings of approximately 1.8 billion Euros in Europe in 2019.


“One of the great healthcare challenges facing our society today is how to get patients on highly-effective treatments while also creating space for innovation,” said Ian Henshaw, Vice President and Head of Global Biosimilars Unit at Biogen.  “Biosimilars provide health systems with viable, cost-effective alternatives, thus allowing for investment in new technologies and treatments in other areas.”


Through a new transaction, Biogen has the exclusive right to commercialize potential ophthalmology biosimilars referencing LUCENTIS® and EYLEA® across the U.S., Canada, Europe, Japan, and Australia. In addition, Biogen has the exclusive commercialization rights for its anti-TNF biosimilars in China.


Learn more about our leadership in biosimilars.