Introduction

In 2019, the North America market for biosimilar was USD xx Billion and it is expected to reach USD yy Billion by 2025. 2015 was the first time when any Biosimilar got approval from US FDA. Since then 26 Biosimilars are approved in the US whereas 15 of those are marketed till date. US market is still not so easy for entry of Biosimilars as pharma / biopharma companies are still preferring more Biologics. The stakeholders need to put up a joint push for adaptability of Biosimilars because the innovators still have strong incentives to save their market share. Other hurdles include threat of patent litigation, development cost, less awareness to physicians and patients about effectiveness of biosimilars, strong incentives for biologics, etc. Still there is some ease in restrictions such as recent US FDA’s new guidelines on Biosimilars interchangeability is one of the welcoming steps. Whereas recent amendment in reimbursements & incentives is also expected to be very useful, such as Medicare Part B as well as 340B programs can be very useful in providing good incentives to physicians for approving / recommending the biosimilars to patients.

Benefits to the US Market

There are plenty of benefits for adoption of Biosimilars such as cost saving on account of patients, more utilization of supply chain, more potential incentives to physicians, etc. Below we are discussing it in little details:

• Cost and Time Saving for Manufacturers: On an average a biosimilar consumes USD 100 Mn to USD 200 Mn of cost as compared to approx. USD 2.6 Bn for reference / innovator biologic. This leads to overall decrease in cost of biosimilars. The first 2 Biosimilars were 15% cheaper than reference biologics in terms of Wholesale Acquisition Cost (WAC).
• Cost Saving Advantage to Employers: employers since they cover upto 85% of employees insurance premium as well as upto 75% of insurance premiums of employers dependents. As per the research the employers can make an annual saving of xx% of their overall spend on specialty drugs treatments for employees.
• Cost Saving Advantage to patients opting for out-of-pocket payments: This will lead to direct cost saving on account of specialty medicine purchasing by individuals.
• More Utilization of existing supply chain: Supply chain of many Biologics was very stringent and only specialty/specific sales channels were allowed. Whereas in case of Biosimilars there will be many sales channels and different types of companies in supply chain will get their pie of business.

Other benefits include Support Programs for Patients, Availability of Pre-clinical & Clinical Data, as well as Real World Evidence generation.

 Below is a small list of Biosimilars which are approved by FDA in recent past.

• Amjevita by Amgen (salt: adalimumab; reference medicine: Humira), in 2016
• Renflexis by Samsung Bioepis (salt: infliximab; reference medicine: Remicade), in 2017
• Mvasi by Amgen/Allergan (salt: bevacizumab; reference medicine: Avastin), in 2017

As per the research segments such as Anti-TNF, Monoclonal Antibodies, and immunostimulants alone will contribute to more than 70% of total expected savings in very near future.

Major Manufacturers

The profiles for major manufacturers include Amgen, Boehringer Ingelheim, Celltrion, Teva, Coherus BioSciences, Fresenius Kabi, Mylan, Biocon, Pfizer, Samsung Bioepis, Merck, Sandoz, & Xbrane Biopharma

Segmentation

Biosimilars Market can be segmented into the following:

By Products:

• Insulin
• Epoetin [EPO]
• Gonadotropins
• Recombinant human growth hormone (rhGH).
• Anti-Tumour Necrosis Factor [Anti-TNF]
• Granulocytecolony Stimulating factor [G-CSF]Interferon
• Monoclonal antibodies
• Others

By Application

• Oncology
• Blood Disorder
• Growth Hormones Disorder
• Chronis and Autoimmune Disorders
• Others

By Region

• US
  • North East
  • Midwest
  • South
  • West
• Canada

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