Follow-on-Biologics – More than Simple Generics

21/10/16

Follow-on biologics promise to reduce healthcare costs, but they are not as simple to develop and produce as generics.

 

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Most of us have experience with follow-on medicines. We buy Acetylsalicylic Acid instead of the more expensive Aspirin®, Paracetamol as an alternative to Benuron® or Acetaminophen - as it's called in the US - instead of Tylenol®.

Once a pharmaceutical patent expires, other companies are free to manufacture and distribute the substance. These copied versions are typically labeled with their so-called international non-proprietary name, which is the chemical description of the active component. Follow-on medicines are 30-70 % less expensive, yet are just as effective. This makes them particularly interesting as a means for reducing healthcare costs – even on a global scale.

Not all follow-on drugs can be lumped together however. There are major differences in the complexity of chemically- and biologically-manufactured medicines. This in turn requires individual development, evaluation and approval process strategies.

Generic drugs – like identical twins

Most follow-on medicines found on the market are generics. They are usually small and simple molecules produced by chemical syntheses.  A generic drug and its reference product contain the same active substance and must be in the same dosage form. If the branded product is a capsule or a tablet, the follow-on preparation also needs to be a capsule or a tablet. When the original is in liquid form,  then so does the generic. The excipients, or inactive ingredients, are the only thing allowed to differ between the reference and generic medicine.

To gain regulatory approval of generic pharmaceuticals, the manufacturer only needs to prove good quality, substance similarity with the reference product and bioequivalence. This means that the new substance is absorbed by the human body in the same way as the original. Generics manufacturers have no need to carry out complex studies to determine the safety and effectiveness of the drug. They can simply refer to previous studies that accompanied the initial product approval. This saves the majority of the developments costs, which are often in the millions. This also explains why generic drugs can be a much cheaper alternative.

Two of a kind – biosimilars

In contrast to the relatively simple small-molecule generics, biologics are gaining popularity in the field of modern medicine where they are used in the treatment of serious diseases such as cancer, multiple sclerosis and diabetes. Biologics are huge and highly complex molecules, mainly proteins. They are produced by living organisms or cells as part of elaborate biotechnology processes. Biologics are characterized by innovative action mechanisms, which is what makes them so valuable.

Many companies around the world are currently developing follow-on biopharmaceuticals, or so called biosimilars. The development strategy differs from that of generic drugs because bio-manufactured molecules always exhibit natural variations. The biosimilar formation is influenced by the production system, the way the cell is cultivated and much more.

In a nutshell, while a biosimilar and its reference product can never be identical, they can have a similar structure and a comparable effect.  To a certain extent, regulatory approval for biosimilars is thus more complicated and requires an enormous investment compared to generics. A wealth of clinical studies is essential in order to valid the effectiveness and the quality of the product and the manufacturing process.

Making quality health care affordable

Patented biopharmaceuticals are high-priced and represent a significant share of health insurers' costs. Although the price gaps between original products and biosimilars are not as high as with generics, these follow-on medicines provide patients around the world economic and sustainable access to state-of-the-art medicines. Biosimilars offer a major opportunity to more effectively manage the healthcare challenges of the future.