Biosimilars

01 Aug Biosimilars

Biosimilars

This article covers “Daily Current Affairs” and the topic details “Biosimilars”. The topic “Biosimilars” has relevance in the “Science and Technology” section of the UPSC CSE exam.

For Prelims:

What are Biosimilars? 

For Mains:

GS3:  Science and Technology

Why in the news?

A collective of scientists and medical professionals has requested the Union Health Ministry and the Department of Biotechnology to uphold strict regulations for biosimilars.

What is Biologics?

• Biologics are pharmaceuticals derived from natural systems, such as humans, animals, or microorganisms. Due to their intricate nature, they offer treatment options for various conditions where alternative therapies are not yet accessible.

• Examples of such medicines include gene therapies, transplant tissue, recombinant proteins, stem cell therapies, and monoclonal antibodies. They are frequently used in the treatment of severe and life-threatening illnesses.
• In contrast to traditional drugs, biologics differ in terms of their source materials, structural complexities, manufacturing processes, and regulatory requirements. Due to these differences, biologics can sometimes be more expensive, leading to accessibility challenges for certain patients.
• To address this issue and enhance access to biological therapies, biosimilars were developed. The purpose of biosimilars is to increase accessibility to these treatments and consequently improve patient outcomes.

What is a Biosimilar?

• A biosimilar product is a type of biologic product that receives approval by demonstrating its high similarity to an already approved biologic product, known as a reference product. 

• The biosimilar must also prove that there are no clinically significant differences in terms of safety and effectiveness compared to the reference product. Minor differences are allowed only in clinically inactive components of biosimilar products.
• Biosimilars are derived from the same sources, such as living cells or microorganisms, as their reference products. Additionally, they possess comparable levels of safety and effectiveness, ensuring they are a reliable alternative to their reference counterparts.

How are biosimilars different from generic medicines?

• While identical generic versions of small molecules can be chemically synthesised, it is not possible to create identical versions of reference biologic medicines, due to their complexity. 
• As a result, the methodologies utilized for creating generic medicines are not applicable to the development of biosimilar medicines.

Differences between Biologics, Biosimilars and Generics:

Prospects: 

• The biosimilar market is projected to reach sales between $14 billion and $31 billion in 2023, accounting for approximately 4% of the biopharmaceuticals market in 2018.
• Biosimilars have demonstrated their ability to capture market share, especially in Europe, and the overall upward trend in the pharmaceutical sector provides a solid basis for their growth.
• The high cost of biologics has made biosimilars attractive to payors and regulators as a way to reduce healthcare spending while still benefiting patients.
• Biosimilars are expected to compete favorably as 12 major biologic products with combined global sales of over $67 billion will face biosimilar competition by 2020 after their patents expire.
• Some companies have exited the biosimilars market, creating potential opportunities for investors in legacy programs at attractive price points.
• The growing demand for lower-cost biologics and the overall growth in the pharmaceutical market driven by population, age, and wealth factors support a positive outlook for biosimilars, with the potential for significant returns on investment.

Challenges in Biosimilars:

• Development risks for biosimilars are estimated to range from 50% to 75% in terms of successfully bringing the product to the market. This stands in contrast to small molecule generics, which boast a higher success rate of around 95%. The extent of biosimilar development risks fluctuates based on factors such as the particular product, production cell line, and regulatory demands.
• Market Dynamics: Each biosimilar and market have unique characteristics and dynamics. Launch and marketing plans must be tailored to individual biosimilars, considering therapeutic areas, patient populations, and geographical drivers.
• Price Competition: Biosimilars often enter the market with immediate price drops compared to reference products. Price wars and aggressive pricing strategies can erode margins and profitability.
• Brand Identity: Establishing a brand identity can mitigate the negative effects of a later market entry and improve adoption by emphasizing quality.
• Limited Awareness and Knowledge: Despite biosimilars being in the EU market for over a decade, awareness and knowledge among physicians, pharmacists, and patients remain relatively limited.
• Resistance to Switching: Patients on long-term biologic treatments may resist switching to biosimilars due to perceived risks or new delivery mechanisms
• Intellectual Property Challenges: Originators use intellectual property portfolios and marketing strategies to defend against biosimilar competition, resulting in fewer launched products in the US.

Indian Regulatory Framework

• Under the Indian regulatory system, biosimilars are referred to as “similar biologics.”
• The regulatory framework for biosimilars in India is governed by the Central Drugs Standard Control Organization (CDSCO) in collaboration with the Department of Biotechnology (DBT). 
• In 2012, they developed the “Guidelines on Similar Biologics; Regulatory Requirements for Marketing Authorization in India” to address the challenges associated with the development of similar biologics. 
• This guideline was revised in 2016.
• Regulation of similar biologics are also governed by the Drug and Cosmetic Act (1940), Drug and Cosmetic Rules (1945), and the Rules for Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells (1989). These regulations were notified under the Environmental (Protection) Act, 1986.

India has become a key global player in producing similar biologics, benefiting from its large market. However, to maintain leadership, Indian pharmaceutical companies must upgrade technology and enhance workforce skills, requiring support from the government and regulatory agencies.

Sources: 

‘Relaxing norms for biosimilars risks safety’ – The Hindu 

plutus ias current affairs eng med 1st August 2023

Q1. With reference to Biosimilars, consider the following statements: 

1. Similar to generic medicines compared to their brand-name counterparts, biosimilars are identical to reference biologic products. 
2. Biologics are medications created from living organisms, encompassing sources such as humans, animals, or microorganisms. 
3. The purpose of biosimilars is to enhance the accessibility of biological therapies and make treatments more cost-effective.
4. Biosimilars are not suitable for treating severe or life-threatening illnesses.

Which of the statements given above is/are correct?

(a) Only one

(b) Only two 

(c) Only three 

(d) All Four

Answer: (b) 

Q2. Which of the following organisations regulates biosimilars in India?

(a) World Health Organization (WHO)

(b) Food and Drug Administration (FDA)

(c) Central Drugs Standard Control Organization (CDSCO)

(d) Department of Science and Technology (DST)

Answer: (c)

Q3. What are biosimilars, and how do they differ from generic medicines? Discuss the challenges associated with them in the context of India.

Gaurav N