By Larry Ramer, DrugPatentWatch writer
A growing number of pharmaceutical companies are looking to simultaneously benefit from the low costs of developing generic treatments and the increased market share and higher prices that true innovations can bring. These companies are seeking to attain all of these advantages by developing treatments that are similar to the standard of care in many ways but have important upgrades. Biologics that are significantly superior to the original standard of care are known as “biobetters,” while small molecules that are meaningfully better than the original drug are known as “supergenerics.”
Biobetters have similar amino acid sequences to the original biologic, but their structures are not entirely identical to the original. Some biobetters target the same molecule site as the original biologics, but do so more effectively and are less likely to degrade than the original product. Other biobetters are supposed to have increased tolerability because they trigger a less potent response by the immune system, while still others destroy pathogens more effectively. More advanced biobetters target different molecule sites or trigger unique responses.
Two examples of biobetters are Margetuximab, which kills certain types of breast cancer cells more effectively than the original biologic, Trastuzumab, and Neulasta which lowers the risk of infection during chemotherapy and requires fewer doses than the original drug, Filgrastim.
Supergenerics are improved treatments that are based on small molecule drugs whose patents have expired. They usually utilize similar mechanism of action to the originals. Supergenerics can have many different types of attributes versus the original drug, including a new active ingredient, an improved manufacturing process, new dosages, altered release schedules, and new formulations. Among the advantages that supergenerics can have over the original drugs are increased convenience for patients, reduced side effects, and enhanced efficacy. Moreover, supergenerics often raise patient compliance rates.
To obtain FDA approval of biobetters, pharma companies have to file the same Biologic License Application, or BLA, as firms that develop completely new biologics. They also receive the same 12 years of exclusivity as companies that create a completely new biologic. A company, however, cannot obtain a 12 year exclusivity extension on a biologic that it or one of its subsidiaries has developed or to which it has purchased the rights unless the firm can demonstrate that the structure, efficacy, or safety of the biologic has been altered.
Conversely, a specific clause in the US Hatch-Waxman law applies to small molecule drugs that are improved versions of previously approved treatments. Specifically, under clause 505 (b)(2) of the statute, companies can rely upon studies that were previously carried out by other entities to partially establish the safety and efficacy of supergenerics. However, companies that apply for approval of supergenerics do have to conduct bridging studies i.e. studies that test the safety and efficacy of any new attributes of the improved drug. Under 505 (b)(2), drug makers are granted three years of exclusivity if they conduct such bridging studies. Pharma companies can receive seven years of exclusivity for supergenerics that treat orphan indications.
Biobetters and supergenerics do not require nearly as many studies as completely new treatments, and biobetters and supergenerics have much greater chances of reaching the market than completely new treatments. Consequently, drug companies can introduce biobetters and supergenerics at much lower costs than completely new treatments. At the same time, biobetters and supergenerics can attain higher market shares and fetch higher prices than biosimilars and generic drugs.
Copyright © DrugPatentWatch. Originally published at Biobetters, Supergenerics Hold Many Advantages for Pharma Companies