Is this the Era of Biosimilars?

Sept 19th, 2017

By: Genpahrm CEO Karim Smaira


Biologic drugs have transformed the therapeutics landscape in numerous areas of healthcare.  They are the most advanced therapies and have revolutionized treatments for patients with serious illnesses like cancer, diabetes, delayed or reversed the course of autoimmune disorders, improved lives of people with rare diseases, and given hope to a community of patients that had previously no effective treatment options. Biologic drugs have nudged traditional small-molecule drugs out of the top sales slots and as a result 8 out of 10 of the world’s top-selling drugs are composed of biologics.

Biologics are protein-based therapeutics that are produced using unique cell lines and are manufactured from natural resources such as human and animal cells, yeast, and bacteria. They are big and very complex molecules, often 200 to 1,000 times the size of more common small-molecule drugs. As a result of their complex makeup and sensitive manufacturing and handling conditions, and also the fact that they typically do not face generic competition after patent protection has expired, biologics drugs are accompanied by a relatively expensive price tags requiring government and insurance funding to guarantee the needed long-term treatment. Owing to the high cost per dose of biologic drugs and with several biologics going off patent in the coming years, there is a high and increasing demand for biosimilar drugs. This implies significant healthcare cost savings, albeit to a lesser degree than seen with small molecule generics.

Biosimilars as the name suggests, are highly similar to an existing approved biologic drug, known as a reference product that is going off patent. However, unlike small molecule generics, biosimilars are not identical to the reference product. They include only the therapeutically active portion of the large molecules biologics and have no clinically meaningful differences from the reference product in terms of safety, purity and potency. Biosimilar manufacturing and review processes globally is more complex, more expensive and require a greater deal of technical expertise compared with traditional generic drugs.

Biosimilars are expected to have a significant impact on the pharmaceutical industry – for both manufacturers and consumers. Many leading biologic drugs, worth more than $81 billion global annual sales, will lose their patent protections by 2020, according to data from Visiongain. As of the end of 2016, the EMA (European Medicines Agency) has approved 23 biosimilars and the FDA (Food and Drug Administration) has just approved its 4th biosimilar product, with the first one being approved only in 2015. Several others developed and regulated markets are following suit. Due to increased competition with the accelerated approvals of biosimilars and their rapid introduction to the marketplace, market conditions will have to evolve to adapt to accommodate more affordable biological therapies thereby increasing patient access. The significant price discounts, as opposed to the branded biologics, will bring more options to the table to drive down increasing drug costs.

According to reports from IMS Health and Deloitte, biologics are already a $150-billion-plus industry globally and are expected to double by 2020, accounting for more than 27% of the pharmaceutical market. Analysts also expect the worldwide biosimilars market to grow, reaching approximately $35 billion by 2020.

The Middle East and Africa Biosimilars Market was worth $0.37 billion in 2016 and estimated to be growing at a CAGR of 32%, to reach $1.63 billion by 2021, according to a report from Market Data Forecast.  The MENA region can be considered as influential and attractive pharmaceutical markets among other emerging markets. Despite the limited number of biosimilars presently available, the region holds substantial potential for the growth of these products. Specifically, the region has an expanding and aging population, unmet medical needs, growing middle class and better incomes, longer life expectancy, and lower mortality rates, increased healthcare spending and access to quality services, and most importantly increased the prevalence of serious diseases. Adoption of a Western lifestyle has resulted in a greater incidence of diabetes, affecting more than 1 in 10 adults, obesity, and increased need for oncology treatments expanding throughout the region.

The MENA region is economically diverse. Although some MENA countries are wealthy, the per capita income in the region remains low. While some countries in the region have managed to modify their healthcare expenditure to include biologic and biosimilar therapies, other countries are finding it more difficult for budgetary reasons. With the government paying the health care bills in many countries, biosimilars and generics are likely to be the drugs of choice for much of the region.

Several countries in the Middle East have established guidelines and regulatory pathways for biosimilar approvals, with the first biosimilar being approved in the region in 2009. Interest and awareness in biosimilar research in the MENA region continue to grow and clinical trials are already underway in a number of countries.


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