Smart approach needed to expand access to ‘biosimilar’ drugs

The Legislature recently considered a bill to help patients access a promising new class of pharmaceuticals. As the current legislative session ends, lawmakers must make sure this bill remains on the docket for quick consider-ation in the next session.

The sooner it’s passed, the sooner Washingtonians will be able to access the advanced class of medicines known as “biosimilars,” which are imitation versions of brand-name biologic drugs.

Biologics are a unique and highly effective class of medicines derived from living things such as cells, bacteria and yeast. These medicines have been a boon for chronic disease therapy, revolutionizing the treatment of diabetes, rheumatoid arthritis, cancer and many other conditions.

Unsurprisingly, these medicines are tremendously difficult to produce. On average, it costs $1.2 billion and takes between 10 and 15 years to gain Food and Drug Administration approval for a new biologic. So they tend to be quite expensive.

That’s why President Barack Obama’s health care reform bill enabled the FDA to approve copycat versions of biologic drugs. These biosimilars should be hitting the market soon.

Right now, though, there aren’t any clear guidelines in place for how pharmacists may substitute these lower-cost drugs. So state legislatures across the country are hard at work developing laws to create a clear pathway for patients to access biosimilars.

Washington is one of the first states that’s crafting legislation. And lawmakers have put together bills in both chambers (HB 1528 and SB 5469) that ensure patients can access these medicines quickly and safely.

Of paramount importance to lawmakers is patient safety.

One reason biologics are so advanced is that they contain about 1,000 times the number of atoms found in conventional pharmaceuticals. As a result, it’s nearly impossible to exactly replicate an original biologic. That’s why imitation versions of biologic drugs are called “biosimilars” and not “generics.”

Biosimilars almost always have exactly the same effect as the innovative biologics they’re designed to copy. But because there are always minor chemical variations between the two, biosimilars can sometimes impact patients differently.

That’s why the proposed legislation would make sure pharmacists only replace an innovative biologic with a biosimilar if the FDA has determined the two can be safely swapped. The proposed bill also requires pharmacists to inform patients and their doctors that a substitution has been made.

As another safeguard, the bill enables doctors to specifically ask for a brand-name biologic if that’s what a patient needs.

These protections are essential. Because drugmakers are among those calling for these precautions, some critics have suggested these measures are only about protecting profits. This simply isn’t true; the proposed legislation does nothing to restrict access to safe and effective biosimilars. In fact, it creates a pathway for patients to receive those products the FDA deems safely interchangeable.

Indeed, without legislation, patients might not be able to access these medicines at all. Without clear substitution protocols for doctors and dispensers, access to biosimilars could get bogged down in inefficiency and confusion.

Washingtonians will undoubtedly benefit from access to biosimilar drugs. Local lawmakers should make sure this legislation is at the top of their agenda next session. That will help ensure that state residents have access to safe, low-cost treatments.