Biosimilars have the same clinical effect as a generic but are only as similar to the original branded drug as validation technologies can confirm.

When a drug company introduces a costly new drug, they can do so because they have an exclusive patent on it. Once drug patents expire, pharmaceutical companies can copy that branded drug, and sell it for significantly less as a generic.

The Hatch-Waxman Act of 1984 — designed to reduce the cost of patient therapies— allowed drug companies to produce generics of off-patent drugs. There are analytical methods to prove that generics are chemically identical to the original branded drug.

The cost to the manufacturer and the consumer is much lower because the approval pathway is much shorter than branded drugs. With the make-up of the drug already approved, generics do not require the added time and cost of research and development.

When pharma processors move to proteins like monoclonal antibodies however, certain sugar molecules exist on the outside surface of the protein. There is a lot of variety in how these molecules are positioned and the analytical methodologies that exist today are limited in the degree to which they can confirm absolute identity of all aspects of the molecule.

Because there is no assurance that the large protein molecule drugs are chemically identical there was debate about calling large protein molecule drugs generic, which led to the birth of biosimilars. Biosimilars have the same clinical effect as a generic but are only as similar to the original branded drug as validation technologies can confirm.

In 2010, The Biologicals Price Competition and Innovation Act was created to modify regulation allowing for lower-priced alternatives. Its intent was to open competition among pricey innovator biologics, defining new pathways for development and approval of alternative near-copies, or biosimilars, of reference biological drugs.

With chemical compositions identical to brand name drugs, generics have become ubiquitous with much lower costs often making them the default choice for healthcare insurers. In some states, unless the doctor specifies the branded drug, the pharmacy will go with the generic. But generics are different than biosimilars because they are considered equivalents.

In the case of biosimilars, the large molecules are still quite expensive to make. The savings are not so much in reducing the manufacturing costs as in just reducing the amount of clinical trials needed to prove the drug is safe and effective.

As biosimilar developers graduate to focus on proteins of higher complexity, requiring higher costs and even more sophisticated manufacturing, they will be challenged to adhere to established processes for proving a high degree of similarity.

When you have a brand new molecular entity, you first have to prove via trials that it works and has limited toxicity. Processors making biosimilars already know what the biological activity and toxicity profiles are, eliminating a good deal of the clinical trials.

With only one biosimilar currently on the market, and two or three to come on the market soon, the jury is still out about their success in the United States. There are many more biosimilars approved and in circulation in Europe. In fact, in some countries biosimilars are the preferred drug and in some places are being pushed by the government-controlled healthcare program.

PMMI’s Healthcare Packaging EXPO, September 25-27 at the Las Vegas Convention Center, will feature resources aimed at meeting a variety of pharmaceutical manufacturing generic and biosimilar demands, including processing and packaging technologies, equipment and materials.

(PMMI, The Association for Packaging and Processing Technologies, represents more than 800 North American manufacturers and suppliers of equipment, components and materials as well as providers of related equipment and services to the packaging and processing industry.)