Build a working knowledge of biological products
Specialty drug prices have skyrocketed in recent years, often making them inaccessible to the average consumer. Biological products, which include biologic and biosimilar medications, fall into the specialty drug category. But one of these biological products – biosimilars – is gaining interest and popularity as it offers people more accessible treatments.
Get to know the differences between biologic and biosimilar medications
What are biologic medications? Biologic medications are made from living sources, such as animal cells, bacteria, or yeast. Because they come from living sources, they can be complicated and expensive to produce. You will often see a biologic called a reference biologic product because it is the first to market. Biologics treat a variety of chronic and severe conditions, including:
Source: FDA
OK, then what’s a biosimilar? A biosimilar medication is very similar but not identical to the original FDA-approved biologic and treats the same conditions. Biosimilars also must be FDA approved, and to be approved there can be no meaningful clinical differences in the safety, purity, potency, and effectiveness of the original biologic. The biosimilar must:
- Be made from the same type of sources as the biologic
- Provide the same benefits when treating diseases or medical conditions
- Be given at the same strength and dosage as the biologic
- Not be expected to cause new or worsening side effects
What does it mean that a biosimilar is very similar but not identical to the biologic? Look at it this way. Because biosimilars and biologics are made from living sources, it is normal for there to be slight variations between batches of the same medication. It’s like loaves of bread made from the same recipe. No one loaf is an exact copy of another, but they are the same type of bread.
So, does that make a biosimilar and a generic the same? Not entirely. They are the same in some ways. For instance, they both may offer more affordable and accessible treatment to patients. But there are major differences.
Source: FDA
Let’s talk about the patient experience
We can’t discuss medications without also discussing how they may impact patients physically and financially.
Will patients have different side effects with a biosimilar? No, there should not be different side effects because a biosimilar is made from the same natural resources as the original biologic, is administered the same, has no meaningful clinical differences, and has the same potential side effects as the biologic.
Then why would someone switch to or choose a biosimilar? A change in insurance coverage due to a biosimilar’s lower cost may instigate switching from a biologic to a biosimilar. And, with increasingly more biosimilars on the market, patients just starting treatment may have greater access to them. But make no mistake, a biosimilar is as safe and effective as its original biologic even though it may cost less and be more accessible. Its FDA approval ensures that.
Will people who switch from a biologic to a biosimilar product need a new prescription? It depends on if the biosimilar is an interchangeable one, which means the biosimilar can be substituted without consulting the prescribing provider. Use of interchangeable biosimilars is subject to state law, but biosimilars and interchangeable biosimilars are as safe and effective as their original biologic.
Some people who take biologics already pay a low price due to manufacturer copay assistance programs. Is that assistance available for biosimilars? Yes, most biosimilar products have copay assistance programs available on their websites.
As biosimilars continue to expand, chances are you’ll hear more about them through the healthcare industry and in the media. You can also look to Blue KC to keep you up to date on biosimilars and other pharmacy-related educational topics.
