Biosimilars

What are biologics?

• Biologics are large proteins (antibodies or those that mimic receptors) made using living material through a complex manufacturing process, which target specific parts of your immune system.
• In rheumatology, the first effective biologics were against a protein called TNF. By blocking TNF in the body, we are able to better control diseases like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. In fact, many times, we can put these diseases into remission.

What are biosimilars?

• Biologics have been available for over 20 years and the first few biologics are losing their patent. This allows other companies to make similar biologics. However, unlike normal generic medications, it is not possible to make an exact copy of a biologic.
• Instead, companies make new medications which are very similar to the originator biologic. They then complete studies that must show their new biologic is equally effective and safe to the originator biologic; it cannot be better or worse. If they prove this, then they have a new medication which is biologically highly similar, or a biosimilar.
• It costs less money to develop a biosimilar than an originator biologic. Because of this, it is also less expensive to purchase a biosimilar, or for your insurance company to pay for it.

What biosimilars are available?

• Currently, biosimilars are available for the originators for etanercept (Enbrel) and infliximab (Remicade).
• For etanercept, the biosimilars are called Brenzys and Erelzi. They are injected once per week just like Enbrel.
• For infliximab, the biosimilars are called Inflectra and Renflexis. They are infused by IV just like and as often as Remicade.

Are biosimilars safe?

• Yes. Health Canada requires that biosimilars are as effective and safe as originator biologics. Biosimilars have been available for a number of years now, with many patients already using biosimilars to treat their disease. Information collected from these patients to date has confirmed the safety and effectiveness of the biosimilars.
• This is the case in Alberta too, where many patients have already been using biosimilars for a few years as a first or second line biologic treatment without any concerns.  Our local experience  suggests biosimilars are safe and effective.

What about switching to a biosimilar?

• In North America, payors are beginning to mandate that patients switch from their originator biologic to a biosimilar, even if they are currently doing well on their originator biologic.
• While this approach may save substantial dollars for insurance companies and government, switching medications when you are feeling well can sometimes feel scary.
• Studies have shown that the overwhelming majority of patients do well with switching. Similar to when patients switch between two similar originator biologics (i.e. Simponi and Cimzia), however, we cannot say for sure that every patient who switches to a biosimilar (i.e. Enbrel to Erelzi or Brenzys) will do well.

If I have to switch, what should I do?

• Most importantly, speak with your rheumatologist and your arthritis care team. No one except you and your specialist understands your medication, your disease and your overall situation with the right expertise and knowledge.
• By speaking to your arthritis specialist, you can discuss what a switch means, if you can or should switch, the insurance process for the switch, and whether you can switch to a biosimilar or another originator biologic instead.
•  Your rheumatologist and you will then be able to closely monitor how you do with the switch, and work together if any problems arise.