Incentives and Challenges in Biosimilar Development

A biosimilar is a biotherapeutic which is almost like an authorized product in relation to the ingredients used and has no significant differences in safety and efficacy. Biologics are much larger than a small molecule, more complex fundamentally and they are created in living cells, then removed and cleaned. In contrast, small molecule medicines are produced solely through chemical synthesis.

According to a McKinsey report, the biosimilars market will be thrice its current size by 2020. It shows how these drugs can transform the healthcare industry. According to the Biosimilars Council report, biosimilars can potentially save costs by up to $250 billion in the coming decade. 

Challenges in Biosimilar Development

Pharma companies around the world face several challenges to cut patient costs. Some of the common challenges that biosimilar companies face in packaging and processing are the variability of large molecules and offering the FDA with enough proof of clinical safety. Here is a comprehensive list of these challenges:

1.Lengthy timelines for production and approval: 

The behavior and structure of the molecules of biosimilars can change drastically due to the conditions under which they are cultured. This can lead to the introduction of impurities, traces of cell protein, and viruses. Also, as the structures of biosimilars are complex, there is a dearth of analytical tools to differentiate between the biosimilar and original therapeutic proteins. 

2.Pricing:

Biosimilars are supposed to be 20% to 40% cheaper than their reference products. However, that’s not the case due to a scarcity of interchangeability designations. As far as pricing, biosimilars have no incentives to be rendered more desirable over brand counterparts. Even if they ease the cost burden, their economic effects in clinical practice continue to be unclear.

3.Nomenclature: 

Nomenclature guidelines will be necessary due to the complex nature of biological molecules as well as biosimilars. Today, nobody follows a consistent way of naming

4.Interchangeability: 

Several issues can come up when swapping patients back and forth between biosimilars and reference products. This is a big barrier in the path of biosimilars and can potentially lead to a major challenge to the markets of reference products. Such interchangeability permits generic drugs to gain market share. However, a few prescribers might be concerned about safety.

5.Recruitment Challenges:

Biosimilar sponsors face several roadblocks in identifying clinical sites even if there are only minor clinical trials. Investigators prefer involvement in research on new treatment advances, unlike follow-on therapies. This leads to promoters moving to non-academic sites, many of whom have no experience and need additional training. 

Biosimilar Incentives.

All these factors can potentially decelerate the time needed for production and approval. When pharma companies target complex proteins, the biosimilar development costs are likely to rise steeply as they face governing challenges to prove any degree of similarity.

This practical price gap may lead to slow uptake of biosimilars, particularly if physicians, insurance payers, and patients are not willing to exchange the reference drug over mounting concerns of efficacy and safety. Also, small price gaps are likely to spur the manufacturers of reference products to stay in the market.

biosimilars, leading to concerns over the resilience of WHO’s International Non-proprietary Name system. Since biosimilars use proprietary names, it can pose a major challenge in places such as hospitals that use non-proprietary names while referring to drugs. 

A major factor for biosimilars to be deemed interchangeable is they must generate similar result as the reference product in a patient. Developers also must have enough proof that swapping patients back and forth between original products and biosimilar does not pose any risk.

In developing countries, recruitment is relatively easier. However, isolated research programs face difficulties in acquiring adequate and timely quantities of reference comparators on account of export/import demands and apprehensions about overage.

There are several financial incentives of Biosimilar Process Development for pharma companies as the reference products often generate large revenues. Biosimilars are often cheaper than the original biologic and attract significant sales.

Biosimilar process development is more streamlined than other molecule types and the risk of attrition and cost is also lowered. Biosimilars do not require to be taken through the Discovery stage, as the medicinal target of the biologic is known beforehand. The second phase is also not needed as the prescribed amount, side effects, and efficacy of biosimilars are the same as for the original products.

The biosimilar sector and its management have grown significantly in the past decade. Several prescribed biologics today are facing patent expiration, so as a result, the biosimilar market is all set for growth. Reorganizing the development process and cutting risks, can potentially help dispel headwinds which is restricting the industry currently. The result should be more launches, a progressively dynamic market and an improved deal for patients.