Biosimilars

What are biosimilars?

Biosimilars are medications that are similar to medicines called biologics. Biologics come from living things, like animal and plant cells, bacteria and yeast. This can make them harder and more costly to produce than synthetic drugs.

Like biologics, biosimilars are made of living things. But they usually cost less. This allows some people to get treatment they wouldn’t otherwise be able to access. It may help to think of biologics as name-brand drugs. Think of biosimilars as generic (less expensive) drugs.

But while a generic drug contains the same active ingredients as its brand-name counterpart, biosimilars and biologics aren’t an exact match. This means that biosimilar manufacturers have to meet strict Food and Drug Administration (FDA) guidelines for approval.

The biosimilar has to:

• Be made from the same types of ingredients as the biologic
• Have the same dosage and strength
• Be taken the same way (for example, as a shot, injection or infusion)
• Provide the same benefits without added risks

What are some examples of biosimilars?

Biosimilars treat several chronic conditions, including:

• Autoimmune diseases
• Blood disorders
• Cancer
• Diabetes
• Inflammatory bowel disease
• Macular degeneration
• Multiple sclerosis
• Osteoporosis
• Psoriasis
• Rheumatoid arthritis

Not every biologic has a related biosimilar. But new biosimilars are constantly being added to the market. Here are some of the most common biologics and their biosimilars:

Can my pharmacist substitute a biosimilar medicine for a biologic one?

Not always. Much depends on whether the FDA considers the biosimilar “interchangeable.” Here’s what this means:

• Interchangeable biosimilar: The pharmacist can substitute it for the biologic without your doctor’s approval.
• Non-interchangeable biosimilar: The pharmacist will have to ask your doctor to approve the change. Your doctor may say yes or no.

This is another way that biosimilars aren’t the same as generics. Pharmacists can usually fill the generic drug instead of the brand-name one. Things aren’t as simple when it comes to filling a biosimilar instead of the related biologic.

What are the advantages of biosimilars in treating disease?

Biosimilars are as safe and effective as biologics. And they usually cost less.

They go through strict FDA testing to ensure they work. The FDA works with each biosimilar maker, so they know the evidence they have to show before getting approval. They have to prove that the biosimilar provides the same benefits as the biologic without added risk.

What are the disadvantages of biosimilars?

Biosimilars are similar to biologics. But not all are “interchangeable.” Your provider may want you to take the biologic version. For example, the biosimilar may have an ingredient or involve a preparation method that may not be good for you.

Should I call my doctor about biosimilars?

Talk to your doctor if you’re taking a biologic and want to know if there’s a related biosimilar. They may switch your medicine. This is often the case even if you started with the biologic.

Your healthcare provider can let you know which form of the medicine you need.