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Lower-cost Biosimilar Drugs: The Solution for High Drug Prices?


by Skye Sherman - August 12, 2019


Photo Credit: by expressess, from Flickr.com
Photo Credit: by expressess, from Flickr.com

It’s no secret that high prescription drug prices are a huge problem—and one that doesn’t seem to be going away anytime soon. Many Americans, and even people around the world (such as China with its cancer drug problem), have a tough time accessing the life-saving drugs they need. Often, this is because the cost of the drug places it out of reach, at an astronomical price set by a drug manufacturer looking to recoup the costs of research into the drug, which prevents the patient from actually being able to secure the drug for the sake of their health.

What can be done about this issue? There are many proposed solutions—as well as problems standing in the way of their potential resolution. Some propose more regulations in America, like there are in Canada, that prevent the drug makers from charging too high of a price for their drugs. This would require a lot of policymaking and bureaucratic hoops to jump through, so in the meantime, patients who need their prescriptions to live and thrive are seeking other options.

One solid option is to purchase the drugs at a lower price wherever possible. This is usually done by purchasing drugs from other countries, where the drug is manufactured at the same quality but for a lower price. At times, the drug’s patent will expire and then pharmaceutical companies can offer a generic version of the drug, which also tends to make the drug easier to access.

Some are also considering the possibility of biosimilar drugs. But what are lower-cost biosimilar drugs? Are they safe and effective? In this article, we’ll dive into the world of biosimilar drugs and try to determine if they are an adequate solution for lowering drug prices.

What is a biosimilar medication?

Before we consider whether biosimilars are a safe and effective alternative to their higher priced counterparts, we must get a solid introduction to them. What are biosimilar medications, exactly?

According to Arthritis Consumer Experts (ACE), “A biosimilar is a biologic medicine that has similar effectiveness, safety, and quality, and delivers the same therapeutic benefits to patients as its reference biologic ‘originator.’ Biosimilars have been approved for use in Canada since 2009. There are 14 biosimilars currently approved by Health Canada.”

In other words, a biosimilar is a drug that is almost identical to the original drug, and is manufactured by a different company, so they can only be manufactured when the original patent expires. The original drug is known as the reference product.

According to the FDA, “A biosimilar has no clinically meaningful differences from a reference product. Studies were performed to show that biosimilars have no clinically meaningful differences in safety, purity or potency (safety and effectiveness) compared to the reference product: Pharmacokinetic and, if needed, armacodynamic studies; Immunogenicity assessment; Additional clinical studies as needed. Studies may be done independently or combined.”

The FDA also assures consumers that “Prescribers and patients should have no concerns about using these medications instead of reference products because biosimilars: Meet FDA’s rigorous standards for approval; Are manufactured in FDA-licensed facilities; Are tracked as part of post-market surveillance to ensure continued safety.”

For Canadian residents, too, biosimilars are said to be safe alternatives to their original drug counterparts. They can be a more cost-effective way to get the treatment a patient needs without paying the high price of the original drug.

“Health Canada has strict, science-based regulatory controls and testing requirements around biosimilars. In fact, all biosimilars authorized in Canada meet the same high standards for quality, safety and efficacy as originator biologic medications. … The leading regulators in the world, including Health Canada, support well-controlled transitions from an originator to a biosimilar biologic. Transitioning to a biosimilar starts with a conversation between a patient and their doctor.”

While no one can claim that a biosimilar is identical to its original counterpart, it still may be a safe and lower-cost alternative that could work for some patients. It is certainly something to consider and discuss. Consumers should do their research and consult with their doctor or another healthcare professional about the safety and efficacy of biosimilar drugs, to help determine if a switch to biosimilars may be the right move for the sake of their health and their wallet.

Is biosimilar the same as generic? Biological vs biosimilar drugs

To most people, biosimilar products sound a lot like generic drugs. This can get very confusing, but biosimilars and generic drugs are not the same thing. While they might serve similar purposes to the consumer, a biosimilar drug is not the same as a generic drug.

According to the Cancer Treatment Centers of America, “Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly name-brand drugs. Both are available when drug companies’ exclusive patents on expensive new drugs expire. And both are designed to have the same clinical effect as their pricier counterparts.

“But biosimilar drugs and generic drugs are very different, mainly because while generic drugs are identical to the original in chemical composition, biosimilar drugs are ‘highly similar,’ but close enough in duplication to accomplish the same therapeutic and clinical result. Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients. But many experts hope the two will share a critical commonality and that, like generics, biosimilars will dramatically lower the cost of biologic drugs.”

Biologics are also different from biosimilar drugs, despite their similar names. “Biologics are life-saving medications made from living organisms, such as living cells that have been modified using biotechnology. This allows these living organisms or cells to produce the active substance of the biological medicine.”

Jamie Joy, PharmD, Director of Clinical Pharmacy Programs for Cancer Treatment Centers of America, explains this difference more clearly: “Branded drugs are either synthetic, meaning they’re made from a chemical process, or biological, meaning they’re made from living sources. Synthetic branded drugs can be exactly replicated into more affordable generic versions, but because biologics involve large, complex molecules, they cannot. That’s where biosimilars come into play.”

So, in short, biologics and synthetic drugs come from two different sources or processes. More affordable, generic drug versions can be made from synthetic drugs, and biosimilars can be created from biologic drugs. Or, said another way: biosimilars are to biologics what generics are to synthetic drugs.

Can biosimilar lower the cost of prescription drugs?

As patents on highly priced biologic drugs begin to expire, many hope that the ability to produce biosimilars will help to lower the cost of prescription drugs overall. In other words, many are holding out hope that biosimilars do for biologic drugs what generic products did for the synthetic pharmaceutical industry.

However, it’s important to remember that biosimilars are comparable but not identical or equivalent to their name-brand counterparts, also called their reference biologic drug. Marketing a biosimilar as identical to the reference biologic drug, or claiming that the biosimilar is equivalent in any way to the biologic, is against the law.

On the other hand, Health Canada also warns against consumers being scared off from using biosimilars, or being discouraged to consider these alternative options because they fear they are unsafe or ineffective. Fear tactics employed by biologic drug makers and advertisers may suggest or insinuate that because Heath Canada “did not issue bioequivalency between the biologic drug and the biosimilar,” the two are significantly different, or the biosimilar poses a risk to the patient. This information is also misleading. So, consumers need to do their research and be informed on both sides.

As the patents expire and more biosimilars get approved and hit the market, it is indeed possible that we will see lowered prices and increased availability and access to life-saving drugs for patients who need them. If biosimilars help to offset drug prices in the way that generics did, it could be very promising news for patients and consumers everywhere.

Benefits of biosimilar drugs

The main benefit of biosimilars is that they cost significantly less than their original biologic counterparts. There are around ten biosimilars currently approved for sale in Canada, and they are anywhere from 25-50% cheaper than their biologic reference products.

A few examples of biosimilars approved by the FDA include Hyrimoz (adalimumab-adaz), the biosimilar of adalimumab (Humira is a common brand), which is used to treat a variety of arthritic diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

The biosimilar of rituximab (brand name Rituxan), a drug used to treat adults with certain types of lymphoma and autoimmune diseases, is CT-P10 (Truxima; rituximab-abbs). Mvasi is a biosimilar for Avastin (bevacizumab), which is used to treat multiple types of cancers, and Kanjinti (trastuzumab-anns, a trastuzumab biosimilar referencing Herceptin) may also be used to treat a few different types of cancers.

There are also some biosimilars being used in the treatment of Inflammatory Bowel Disease (IBD). According to an article published on the National Center for Biotechnology Information website, “The main benefit of using biosimilars in patients with inflammatory bowel disease (IBD) is reduced drug acquisition costs. … Biosimilars are less costly than originator biologic agents primarily because biosimilars do not have to undergo the intensive clinical development process associated with approval of an originator. Furthermore, biosimilars do not incur high costs for marketing, market access, and postmarketing research and development. Thus, an opportunity exists for savings, and those savings can, potentially, be passed onto consumers and payers.”

Clearly, as biosimilars gain more steam and receive more attention and research, they could drastically change lives around the world, including those of cancer patients.

Development and future perspective on biosimilars

The future looks promising for biosimilars. They could help to improve health care coverage and make prescription drugs more affordable. Big news came out of Canada recently when it was announced that one province had passed legislation that demonstrated support for biosimilars.

A recent article in the Canadian HR Reporter shares, “British Columbia has become the first province to legislate a changeover to biosimilar drugs—a move that could save employers thousands of dollars on health benefits, according to experts. … [The changeover will] affect more than 20,000 patients with chronic conditions, according to the government.”

And, at the end of the day, it just makes sense. Biosimilars have the potential to change the game just like generics did. They could help to make health care and necessary prescription drugs more accessible to the patients who need them, saving lives and changing the face of healthcare for good.

In an article for The Globe & Mail, president and CEO of Green Shield Canada, Zahid Salman, sums it up nicely. He writes, “Biosimilars—drugs that are nearly identical to the original product, but produced by a different company—are a rarity in health care: An opportunity to provide patients with a treatment that works just as well, but at—sometimes—half the price. The decision to embrace biosimilars is not a difficult one—it’s just logical.”

Salman continues, lending support to the safety and efficacy of biosimilars, saying: “Biosimilar transitioning has been well-established in scientific literature as safe and effective. In fact, more than 90 individual studies with 14,000 patients across seven disease states and eight countries have demonstrated the safety and effectiveness of this approach. This mountain of evidence is rarely seen in any other health-care decision making. However, this evidence is often forgotten or drowned out by a sea of perceived and potential concerns that have no basis in practical reality or evidence.”

As biosimilar drugs grow in popularity and presence like generics did, it could mean that more and more patients are able to access the life saving medications they need. Whether the patient is suffering from cancer or IBD, all it takes is a discussion with their doctor to explore the possibility of transitioning to a biosimilar and being able to access a more affordable alternative.

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