Biosimilars Handbook

Biosimilars in Action: Why Does  Europe Have Greater Access?

More than a decade of patient use of biosimilars in the E.U. has shown no difference in health outcomes between patients who use a biosimilar and those who take the originator biologic medicine. The European Medicines Agency (EMA) laid out a framework for developing and marketing biosimilars in 2004 and approved the first biosimilar for use in the E.U. in 2006. Since then, dozens of biosimilar medicines have been approved and used by patients in the E.U. Total sales of biosimilar medicines in the E.U. approached an estimated $500 million through 2014.

Since they were introduced, biosimilars have been used broadly throughout the E.U. to treat patients. In fact, the biosimilars approved for use in the E.U. have an estimated combined 700 million patient days of clinical experience in markets around the world, confirming their safety, efficacy and quality. Cost savings in Europe from biosimilars is estimated to range from $16 billion to $43 billion by 2020.

Furthermore, the six established therapy areas with biosimilar competition consistently demonstrate reduced average list prices. Overall, this increased competition resulted in greater patient access in the whole European market. There are many similarities between the U.S. and EMA processes, but, unlike the U.S. regulations, there is no E.U.-wide legal designation for ‘interchangeable’ biologic products; EMA approves biosimilar products based on the scientific data, and each Member State determines whether biosimilar and reference biologic products are able to be switched by health care professionals or substituted by pharmacists.

“As every rheumatologist knows, the biggest downside about biologics has been their price, and inevitably and appropriately there’s been some restrictions almost wherever you practice. And so I guess the excitement about biosimilars, at least in the UK, is that they will be a bit cheaper, and that ought to enable us to treat more patients appropriately.”

John Isaacs, Professor of Rheumatology
Newcastle University, U.K.

Bringing Biosimilars to Patients in the U.S.

“[W]e [FDA] still need to be taking meaningful steps to get more low cost alternatives to the market, to increase competition, and to give consumers more options. This is especially true when it comes to complex drugs and biosimilars.”

Scott Gottlieb, M.D.
U.S. FDA Commissioner

Currently, European companies that want to manufacture and market a biosimilar product are required to submit quality and comparability data. The extent of this scientific process varies by medicine type and each biosimilar is evaluated on a case-by-case basis. Of the approved biosimilars on the market in the E.U., there are multiple therapies that treat many conditions.

The first-ever biosimilar, Sandoz’s Omnitrope® (somatropin), was approved by the EMA in April 2006. Omnitrope is a recombinant human growth hormone indicated in children for treatment of growth failure due to Growth Hormone Deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome and Idiopathic Short Stature, as well as in adults for treatment of either adult onset or childhood onset GHD. Since 2006, the EMA has approved biosimilars for the prevention and treatment of various disorders related to blood clots in adults, as well as biosimilars to treat rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer. These products give patients an approved therapeutic alternative to the brand product, but at an average price of 30 percent less than the brand biologic.

Biosimilar medicines have the same safety and efficacy profiles of biologic medicines (reference products). Thus, manufacturers of biosimilars remain committed to creating safe and effective products that undergo a comprehensive FDA review. Their acceptance and availability will ensure sustained access to a supply of important, lifesaving medications for patients. Biosimilar use in the U.S. can and should increase; manufacturers, government and regulatory groups must work together to create policies where patient access is a top priority.

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