Innovation

In continuing their history of relentless innovation towards developing novel therapies to address high unmet medical needs, Biogen has expanded their operation into the field of biosimilars . Over the past year, they brought their first biosimilars to market, reducing cost barriers that can impede patient access to treatment for autoimmune conditions. Biosimilars are analogous to “generic” medications, except that biosimilars are copies of originator biologics, while generics are copies of small-molecule medications. Biologics are much larger, more complex molecules derived from living cells, making them much more challenging to develop and manufacture than small-molecule generics. Having already successfully engineered originator biologics for over 30 years, Biogen is currently one of very few companies with the immense scientific expertise and leading manufacturing proficiencies required for consistent development of high-quality, life-changing medications.

Biogen’s two European Union approved biosimilars include Benepali and Flixabi, which are used to treat painful and debilitating autoimmune disorders. These have been instrumental in expanding patient access to lower-cost medicine, and reaching patient segments that were previously excluded from high-quality medication regimens due to its excessive costs. Biogen’s collaboration with Samsung Bioepis Co., Ltd has allowed them to share resources and knowledge, leading to the successful development of these medications. According to research released in 2016 by the IMS Institute for Health Informatics, the adoption of biosimilars in the European and United States markets are expected to bring healthcare savings of $110 billion over the next four years. Furthermore, patient access to biologics has increased by 100% since biosimilars entered the market in the European Union. Furthermore, Biosimilars in the EU have on average provided savings between 25-30% compared to their biologic counterparts. Similar savings are expected to be realized in the US based on the results of several studies analyzing the potential impact of biosimilars in the US market. With the biosimilar development industry still in its infancy, these savings margins may grow even larger as the replication processes are streamlined.

Inspiration

Biogen’s inspiration for creating low-cost, high-impact medications is embedded in their recognition that business must play a significant role in making the United Nations Sustainable Development Goals a reality. With billions of dollars of biologic medications patents set to expire in 2020, Biogen saw a massive opportunity to bridge their scientific expertise and manufacturing excellence to revolutionize cost and access to these medications. While developing these medications was not always easy, it was a powerful means of making their therapies accessible to more people. According to the director of sustainability at Biogen, "the timing of biologic patents expiring was critical” for Biogen’s initial drive to create biosimilars, “but what it came down to in the end was the opportunity to reach so many patients who were unable to access affordable medication.” Touching people's lives in a positive way is what energized employees in the company from top-to-bottom.

Flixabi and Benepali are both considered anti-TNF therapies, used for treating common conditions such as rheumatoid arthritis (approximately 1.3% prevalence globally), inflammatory bowel disease (0.4% prevalence in the US), psoriasis (0.09% to 11% prevalence reported in countries across the world) and several other autoimmune-related disorders. According to PM Live's Top 50 Report, anti-TNF biologic agents held three of the top five spots for the highest annual global sales for a medication. Combined, these three medications (Humira, Enbrel and Remicade) amounted to over $30 billion global sales annually. Biogen seeks to cut into this market by adding their two anti-TNF biosimilars, while maintaining their tradition of offering a diverse profile of drug therapies for every disease they seek to eradicate. Additionally for Biogen, pursuing these specific biosimilars that target disease with high prevalence across the world, provides them with the ability to make a positive impact on the highest number of people possible.

Overall impact

Biogen views the impact of their successful biosimilar development to be two-fold: 1) Save healthcare systems across the world millions to billions of dollars a year, and 2) Increase access of biologics to people in need. The positive impact on these people’s quality of life is immense, and keeps Biogen determined to create safe, effective biosimilars. Also Biogen feels that creating biosimilars will drive the pharmaceutical companies that created the originators to continue to innovate, and create more competition. Since the company that creates an originator biologic essentially has a monopoly over the medication and price, the introduction of biosimilars provides healthy competition for creation of new medications.

Business benefit

In Biogen's eyes, the business benefit is clear, “biosimilars are allowing us to reach untapped markets in need of these medications.” By reaching a new target market, Biogen is capable of creating value for their business, while also providing value to the people using their medication. With the two successful introductions of Benepali and Flixabi into the European domain, Biogen has taken a hold of the biosimilar market with a proven track record of excellence. They have created a sustainable advantage over other smaller companies which will struggle to have the flexibility to create biosimilars whenever patents for biologics expire. Biosimilars add a new dimension to Biogen's current therapeutic profile, allowing them to fully take advantage of their premier scientists and manufacturing facilities.

A significant portion of Biogen's current growth has been attributed to its portfolio of biosimlars, where Benepali for instance has grown from under $3 million in sales during Q1 of 2016, to over $30 million of sales in Q3 of 2016. This immense growth in revenues for Benepali exemplifies the business potential for innovations that reduce costs across the health system while maintaining the highest quality of medical therapy.

Social and environmental benefit

Under UN Goal # 3 (Good Health and Well-Being), Biogen's venture into biosimilars most closely resonates with the 8th target listed under this goal: to achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. Biogen is helping make this UN goal become a reality with their new profile of biosimilars. Since Flixabi and Benepali are expected to provide an impressive 30-40% reduction in price compared to their biologic originator counterparts, they will help make significant strides towards achieving the UN goal of providing access to safe, effective, quality and affordable medications to all. Although Flixabi and Benepali have just been released into the EU markets over the past year, the potential for increased accessibility can be hypothesized based on data from a previous biosimilar launch in the UK. In this case, Filgrastim (a biosimilar for Neupogen) was introduced to the market in 2008, at a time when growth of Filgrastim uptake had come to a halt. Then, in the six years following its introduction, the number of standard unit uptake of Filgrastim (biosimilar or originator) increased by 104% in the UK. This highlights the significant role biosimilars may play in expanding access to medicines.

The ability for biosimilars to improve patient health and optimize well-being cannot be underestimated. Relieving debilitating symptoms for people who live with severe autoimmune disorders will be drastic for patients who could not previously afford the medication, as well as in countries who deemed the originator biologics too expensive to be approved. In creating these medications, Biogen has collaborated with some of the brightest innovators in the industry and strive to feed off these relationships to achieve the seemingly impossibly: curing intractable diseases. While the social benefit is a clear result of their biosimilar development, Biogen's commitment to the environment is reflected in their complete business operations, which have been certified as carbon neutral for the past two years. This dedication to excellent innovation in scientific, social and environmental progress is exemplified throughout the organization and is also evident in the development and manufacturing of biosimilars.

Interview

Johanna Jobin, Director, Global EHS & Sustainability