Connecticut has made many investments in the life sciences as a way to create a stronger jobs base and economy.

Incentives for biopharma research and development, stem cell and regenerative medicine research funding, and the construction of the Jackson Laboratories campus in Farmington are just a few of these strategic investments.

Connecticut bioscience
Connecticut must leverage its strengths and embrace innovation, not build roadblocks to job creation and economic growth.

That's why it's surprising that passage of HB 7118, which facilitates the use of cost-saving biosimilar versions of biologic medicines, is proving to be so difficult.

Reviewed favorably by the General Law and Public Health committees, HB 7118 now awaits action from the state House.

Similar legislation has passed in 27 states, including the states we compete most intensely with for biopharma investment and jobs, Massachusetts and California.

The problem seems to be a misunderstanding about what biosimilars are—and are not.

First, some background:

After a patent expires on a drug, FDA-approved manufacturers are allowed access to the recipe created by the company that invented the medicine.

Generic manufacturers can charge much lower prices for their copy of a drug because, to make a profit, they only need to cover their manufacturing and distribution costs.

They have no research and development costs.

Biosimilars are analogous to generics. Biosimilar manufacturers use inventor company recipes to make their medicines.

Because they are large molecule compounds and biologically derived—versus generic medicines, which are small molecule compounds made essentially by pressing their chemical ingredients together into pills—biosimilars are described as “similar,” therapeutically equivalent,” or “interchangeable,” rather than as copies.

Biologics treat the most severe diseases, like cancer, multiple sclerosis and advanced arthritis. The costs associated with researching and developing biologics and of research and developing their complex manufacture in bioreactors are expensive.

So, like generic medicine, biosimilar versions, free of research and development costs, are much cheaper—helping reduce healthcare costs.

Legislation Languishes

Why, then, is the legislation languishing?

Perhaps, because, as large molecule drugs, they are administered by injection or infusion. Some worry that anything so complex may be too difficult to copy accurately.

But the federal FDA has expended a great amount of resources studying biosimilars and, most importantly, creating a thorough, reliable regulatory pathway to approve biosimilars.

Connecticut must embrace innovation, not build roadblocks to much-needed investments, job creation, and economic growth.
The FDA process is designed to confirm therapeutic equivalence—in terms of safety and effectiveness—to the original biologics medicines their manufacturers have re-produced.

Because biologics treat what would otherwise be among the most intractable of diseases, physicians prescribing them overwhelmingly are specialists and deeply aware of how the medicines work.

If a physician, for any reason, believes a patient should have the biologic original brand name medicine and not its biosimilar, HB 7118 specifically states that he or she can require no substitution.

Barring such a reason, we believe physicians will likely welcome the biosimilar option as a means to lower the substantial treatment costs associated with the diseases treated by biosimilars.

Biosimilars are safe and effective.

They are innovations that Connecticut—“the bioscience state”—should embrace, not build roadblocks against.


For more information, contact Connecticut Bioscience Growth Council executive director Paul Pescatello (860.244.1938) | @CTBio