What Is a Biobetter?
Understanding This Drug's Role
The term biobetter refers to a recombinant protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters build on the success of existing, approved biologics but are considered less of a commercial risk than developing a brand new class of biologic.
Biobetters are not entirely new drugs and they aren't generic versions of drugs, either. While many consider biosimilars to be generic versions of biotech drugs, it isn't possible to create a generic biologic drug. That's because biopharmaceuticals are produced in living organisms - such as animals or bacteria - and cannot be copied exactly.
Congress has authorized the US Food and Drug Administration (FDA) to develop a regulatory approval pathway biosimilars, but the process is a complicated one which must address many concerns, and the pathway has not yet finalized.
Rather than wait for the process to be completed, some drug manufacturers are opting to invest in the development of biobetters.
Advantages of Skipping Biosimilar Development in Favor of Developing a Biobetter
First generation biologics -- such as insulin and early recombinant forms of human growth hormone - are generally immediate-release drugs that are delivered via infusion or subcutaneously. Biobetters are being developed using protein or glyco-engineering which, experts say, reduces the risk of immunogenicity, makes the drug safer and more effective, and requires lower dosing. A biobetter has the same target as the original biological, but its effect on the target lasts for an extended period of time.
Because a biobetter is a new drug, it will enjoy 12 years of market protection in the US and other markets, unlike a biosimilar. In addition, biobetters tend to have lower R and D costs.
Many of the first generation biologics are going off-patent and will face competition from biosimilars.
It remains to be seen if biobetters will be competitive.
Companies Developing Biobetters
Novo Nordisk, Merck & Co, Roche Group, Biogen Idec, Amgen, Sanofi-Aventis, Eli Lilly, and GlaxoSmithKline have all expressed interest in the development of biobetter drugs. Several are acquiring smaller, innovative biopharmaceutical companies that have promising pipelines.
For example, British pharma AstraZeneca purchased the biotech company MedImmune which intends to focus on biobetter R&D.
The Edmonton, Alberta, company Compass Biotechnologies, Inc., announced in late December 2011 that it is focusing on development of improved biosimilar proteins such as EPO and G-CSF.
Compass also has an agreement to source recombinant protein biosimilars manufactured in "CHO" cells from PanGen Biotech of Seoul, South Korea, and an agreement with Arecor Ltd. of Cambridge, England, to develop a biobetter, heat-stable formulation of the commercial hepatitis B vaccine.
K. Srinivas Sashidhar, a research analyst with Frost & Sullivan, wrote that "Biobetters will be the next big opportunity for biopharmaceutical companies and CROs. Market participants may look forward to collaborations with these companies in order to develop the improved versions of biologics. Organisations well known for innovation and experience with generics might be best positioned to achieve success with biobetters."
Some of the biggest challenges facing researchers involved in the development of biobetters are to achieve similarity to the originator molecule and obtaining access to originating company's data, according to Sashidhar.
Also Known As: biosuperiors
The German biotech company Glycotope is developing TrasGEX, a biobetter of Roche's enormously successful oncology drug Herceptin (trastuzumab). TrasGEX targets the HER2 receptor which is over-expressed in certain cancers, including HER2-positive breast and abdominal cancers.