The introduction of biosimilars into the U.S. market represents a massive shift in the pharmaceutical industry. However, many believe that the bigger story relates to the group of products known as biobetters, which are biologic drugs that leverage the infrastructure of an existing biologic but deliver an improved product from some clinical characteristic. Some healthcare experts believe that the impact from biobetters will outweigh that of biosimilars. Manufacturers, payers and providers need to better understand what biobetters mean for the healthcare network.
What happens when big pharma develops a biobetter? Analysts believe that Roche’s Gazyva will be one of the first to initiate this trend. The product expects to replace Rituxan, a consistently well-performing drug for certain indications. A review of this market basket reveals the efforts of several small manufacturers to introduce biosimilars in the same therapeutic area. An article from BioPharma-Reporter calls out the risk for these manufacturers, specifically if Gazyva obtains approval and rises to its clinical efficacy expectations. While improved value is an advantage that biobetters have over biosimilars counterparts, there is some downside, including more substantial trials (translating to more extensive development costs for manufacturers) as well as the higher price tag for patients at the point of care. Many payers still favor biosimilars over biobetters as coverage for biobetters aligns much more with existing biologics, causing more cost control concerns.
As it relates the cost to pharma, the average biotherapy development cycle cost around $5 billion and can take up to 15 years. Those figures don’t buy you a guarantee that you will hit the market, with 19 in 20 drugs failing to obtain approval. Biobetters offer some salvation with significantly less time and money required to introduce treatments into the market. However, with too few data points, that theory has yet to be validated. Many healthcare professionals advocate for biobetters, considering their superior efficacy and patient value. Over the next few years, the market will demonstrate whether the medical advantages and similarity to proven in-market drugs outweighs the cost and continued coverage complexity that biologic pharmaceuticals add to the healthcare market.
The success of some biobetters hinges upon the agent’s ability to improve treatment convenience. In fact, many manufacturers looking to deploy a biobetter heavily invest in convenient dosing through long acting formulations and more advanced drug delivery technologies. These innovations in biological drugs could result in significant commercial and regulatory advantages in the market. The originator biologic makes biobetter deployment much more tangible as the product is considered interchangeable from a clinical perspective.
Experts forecast biobetters to have significant impacts on the growth hormone market basket. The seven treatments in the pipeline for this space are biobetters. Complex market access in this therapeutic area remains a challenge for manufacturers entering the space. The case study around Sandoz’s Omnitrope’s launch highlights some of these challenges. Even though its price was 30% lower than Genotropin, prescription uptake started off with a sluggish launch. Industry stakeholders are hopeful that biobetters will penetrate this market through advanced delivery options and clinical efficacy along with the right combination of patient support programs and more competitive contracting with payers.
Depending on how payers, providers and patients receive this new group of products, biobetters could end up stealing the spotlight away from biosimilars. Contingent upon on how competitive these products are from a price and effectiveness perspective, the development of biobetters may prove to be a more lucrative business model for pharma than that of originator biopharmaceuticals.
Stay tuned for more developments within specific therapeutic classes.