In the current scenario, the global biosimilar industry is at a very nascent stage. Biosimilar drugs have gained popularity in the last five years owing to several advantages associated to them, the major factor being, cost reduction. They have a strong potential to reduce cost of biological treatments for chronic skin diseases such as psoriasis.
The concept of biosimilar is fairly new and the awareness is gradually increasing among industry experts. A recent report published by Allied Market Research highlights the current trends, opportunities and the challenges of the biosimilar market. It further offers insights such as the market share, size and growth. The progress and advancements in the medical field will further boost the prospects of the biosimilar market.
Drug approval in the biosimilar market
There is a significant amount of different between biosmilars and generic biologics. According to Dr. Kircik, there cannot be a generic of a biologic as every biologic is formulated differently and thus it is essential for everyone to realize that biologics are not similar to biosimilars.
The approval process for biosimilars and generics is completely different. The Biologics Price Competition and Innovation Act of 2009 marked the onset of biosmilars in the market. Biosimilars have an abbreviated licensure pathway which is different in comparison to a generic pathway.
The manufacturers of biosimilar drugs need to show or prove that there is no change in the parameters such as safety, potency and purity of the biosimilar drugs and the reference product. Further, biosimilars must have the same action mechanism, dosage form, route of administration and strength as their product that is used as reference. Biosimilar products may not always get the approval even if the parameters are more or less the same as that of the reference product.
Till February 2017, only 4 biosimilars have got the green signal in the U.S. Zarxio, biosimilar of Neupogen was the first biosimilar to get the approval which was followed by Inflectra in April 2016. Erelzi and Amjevita soon gained populairity in April 2016 and August 2016 respectively. There are around 40-50 drugs that are undergoing trials in the U.S. and Europe. According to a study, the U.S. could potentially save around $44 billion in the period from 2014 to 2024 with the development of new biosimilar drugs.
Biosimilar market in Asia-Pacific
The development in science and technology has influenced the arrival of biosimilars in the western markets such as the U.S. and Europe. The focus to develop biosimilar drugs is high in the developed economies compared to the developing economies. However, the trend is gradually changing as several countries in Asia-Pacific such as India and China are investing heavily in the development of biosimilars.
The biosimilar market in the Indian sub-continent has a tremendous potential to grow owing to increase in the number of complex biologics going off-patent. Further, the launch of products that are new, increase in awareness and acceptance of biosimilar and onset of new market players such as Aurobindo Pharma has propelled the prospects of the biosimilar market in the region. The life science firms are heaviliy investing in the development of biosimilar to take advantage of the untapped growing opportunities. In order to server the local and offshore markets, Indian companies are establishing manufacturing units in various countries. Several companies are collaborating with each other in order to establish a strong presence in the market. In February 2017, Aurobindo Pharma acquired TL Biopharmaceutical, a company based in Switzerland. This collaboration has led to development of the organizations product range in biosimilar.
The biosimilar market worldwide is staring at a bright future owing to the several advancements made in the field of medicine. Researchers and scientists are striving hard to develop new biosimilars that are cost-effective and efficient. The approval of new biosimilar products could potentially open the door to new biosimilars in the market. The manufacturing and awareness of biosimilar is higher in the developed economies. However, Asia-Pacific has a high market potential as several manufacturers are collaborating with each other to establish a presence in the biosimilar market.
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