For Apotex and others, 2016 brings optimism for burgeoning biosimilar market

Author: Charles Geiger

Canada is well known for the universal health care the country provides its citizens. While Canadians can see a doctor for free, the prescriptions they receive are often not covered by the Canada-wide health care plan. This means many Canadians, the majority of them who are seniors on a budget, have to pay hundreds of dollars monthly out of pocket to cover their prescription costs.

According to a recently released Angus Reid poll of Canadians, “More than 20 percent of people said that they – or someone in their household – didn’t take medicine as prescribed because of the cost.”

The report also found that Canadians on tight budgets will skip doses or split pills to make a prescription last longer. The public interest research company also reports that the majority of Canadian residents believe prescription drug costs should be covered by the universal health care plan.

Generic drugs have greatly reduced the cost burden associated with pricey name brand medications. Generics are made of the same active ingredients as their name brand counterparts, however, they often cost a fraction of the price. With the success of the generics industry, pharmaceutical companies have begun looking into manufacturing biosimilars, also known as Subsequent Entry Biologics (SEB), as the latest frontier in the world of big pharma.

“Biosimilars are biologic medicines (drugs derived from living organisms) that enter the market after the patent expiry of a previously authorized version and, with demonstrated similarity to a reference biologic,” explains the Huffington Post.

Like biologics, biosimilars can treat a number of diseases, like cancer, rheumatoid arthritis, Crohn’s, diabetes, growth deficiencies, or psoriasis — at a significantly reduced cost. While biosimilars may be a new term to the majority of Canadians, the national market for these drugs is extremely large.

In 2014, biologics sales accounted for “$5.6 billion or 24 percent of the entire Canadian market for pharmaceuticals and included four of the top five best-selling drugs in Canada,” Bruno Mäder, Head of the Biosimilar Business Unit, Merck Canada Inc., told the Huffington Post.

Biologics are very pricey, which is why their less expensive counterpart, biosimilars, are being touted as the new wave in the pharmaceutical industry. Apotex, one of Canada’s leading generic drug manufacturers, is very interested in the emerging biosimilars market. In 2014, Apotex announced it had various biosimilars in the pipeline and was especially excited about a cancer treating biosimilar.  The company has already brought one biosimilar to market in 2016.

In order to pass real value to customers, biosimilars will need to be reviewed and added to provincial drug plans across Canada. The addition of biosimilars to these formularies will help reduce the cost incurred by customers, while also allowing drug companies the opportunity to invest in new treatments. The sooner biosimilars are approved and added the better, as many patients could benefit from reduced biosimilar costs and treatments.

When biosimilars are added to country wide formularies, it is estimated that they will save the Canadian health care system $4 billion dollars annually.  “It saves the system money and therefore makes it possible for the system to expand coverage to more people,”  Steve Morgan, a professor at the University of British Columbia’s School of Population and Public Health, told the Financial Post.

In an effort to persuade the federal government of the viability of biosimilars, the Canadian Society of Nephrology released three papers in 2014 evidencing the efficacy and safety of  Subsequent Entry Biologics (SEBs), the potential cost savings of biosimilars, and their general impact on medicine.

Vanessa Milne of Healthy Debate points out: “Like their generic counterparts, SEBs, which are approved by Health Canada on a drug-by-drug basis, require less proof of safety and efficacy than new biologics.” That’s something that may speed up the approval process.

To vet biosimilars, Health Canada compares the pending SEB to the previously approved biologic and looks at non-clinical studies. For the approval of biosimilars, clinical trials are less important because biosimilars are deemed similar enough to the original biologic for some of the information to be transferable.

The advent of biosimilars is also impacting another growing issue of concern: sustainability. Experts believe biosimilars will help the industry remain sustainable and will help make many needed medications affordable.

“Biosimilars deliver similar clinical outcomes to their reference biologic products, but because they are less costly to develop, international analysts are reporting that they have the potential to generate an estimated $50 billion in savings for health-care systems,” said Gerry Stefanatos, Corporate Vice President at Hospira.

Biosimilars have the potential to drive down medication costs, while simultaneously providing high quality treatments to very serious illnesses. As more biosimilars emerge on the market, consumers will benefit from variety and competition within the pharmaceutical industry, which will help further reduce the cost associated with these new medications.