However, longer-term solutions involve investing in the prevention and lowering of actual drug expenditure. Any form of financial plastering and insurance plans may help in the short term.

In the United States healthcare expenditure was $3.3 trillion in 2016 where $329 billion was spent on prescription drugs. There is an urgent need to reduce the drug development and manufacturing costs. Nevertheless, the administration of biosimilars in an ageing population is resulting in healthcare payer systems, public and private, to struggle particularly in a post COVID-19 world. Nevertheless, market access and reimbursement remains the biggest challenge for these while mAbs commercialization routes are relatively well established. The gene and cellular therapeutic approaches are rapidly increasing for phase 1 development. This does look like a daunting number but most of them are withdrawn at phase 1 human clinical trials and only 23% of those, which reach phase 2 trials, make it to the market. There are currently 214 approved mAbs with almost around 1000 under development for several indications in various phases of development ( Figure 2). The global biosimilars market is predicted to reach to $35 billion by 2020 while the mAb market is expected to exceed $65 billion by 2023. In future years, patent protections will soon expire ( Figure 1), and subsequently initiate a new wave of development of biosimilars and biobetters. Therapeutic glycoproteins account for more than two-thirds of recombinant therapeutic proteins on the current market, whilst also seeing the number of approved therapies increasing each year. Herein we review the biologic TNFα inhibitors, which are on the market, in development, and the challenges being faced by biosimilar manufacturers.Īs a result of substantial growth during the past decade, the biopharmaceutical industry is at the forefront of clinical care, with monoclonal antibodies (mAbs) generating the highest revenue. Successful penetration of biologics can drive down prices and this will be a welcome change for patients and the healthcare providers. Glycan variants can significantly affect the quality attributes requiring characterization throughout production. Although in principle, market-share should be available, withstanding that the challenges regarding the compliance and regulations are being resolved, particularly with regards to variation in the glycosylation patterns and challenges associated with manufacturing. Five blockbuster TNFα mAbs, considered as first line biologics against RA, are either at the end of their patent life or have already expired and manufacturers are seeking to capture a significant portion of that market. mAbs have remarkably changed the treatment landscape, establishing their superior efficacy over traditional small chemicals.

This article brings these costs to the forefront with a focus on biosimilars being developed for Rheumatoid Arthritis (RA). It is imperative that academics and relevant companies understand the costs and stages associated with biologics processing. The development costs of biosimilars are significantly higher than their generic equivalents due to therapeutic equivalence trials and higher manufacturing costs. As the world’s best known mAbs are close to facing patent expirations, the biosimilars market is poised to grow with the hope of bringing prices down for cancer treatment and autoimmune disorders, however, this has yet to be realized. Healthcare systems worldwide are struggling to find ways to fund the cost of innovative treatments such as gene therapies, regenerative medicine, and monoclonal antibodies (mAbs).

Intacept cost