Biopharmaceutical Alliance

Why in news?

Recently, the biopharmaceutical alliance was launched to build a resilient supply chain in the biopharmaceutical sector.

What are Biopharmaceuticals?

• Biopharmaceuticals are complex medicines made from living cells or organisms.
• Production – They are often produced using cutting-edge biotechnological methods.

• Types – There are two classes of biopharmaceuticals.
• Biologics – It include medicines that generally come from living organisms, which can include animal cells and microorganisms, such as yeast and bacteria.
  • Insulin became the first biologic cleared for human use in 1982.
• Biosimilar – It is a biologic that is highly similar to another biologic that is already patented (original biologic).
  • A human growth hormone was first biosimilar, which was approved in Europe.

• Biologics cannot be copied exactly, and so biosimilar are not identical to their original biologic.
• Usage – They are potential for precise and targeted treatments, usually injected into the body.
• Challenges – They tend to be heat sensitive and easy to contaminate.
• They are difficult and expensive to make, store and transport.

What is Biopharmaceutical Alliance?

• Need – There was a huge drug supply shortages seen during the Covid-19 pandemic.
• The production of essential raw materials and ingredients of pharma products are concentrated in a few countries posing a greater risk in supply chain.
• Formation – It was initially organized during the U.S.-Korea Critical and Emerging Technology Dialogue in 2022.
• The first meeting of the Alliance was held in San Diego during the Bio International Convention 2024, the world’s largest biopharmaceutical exhibition.
• Members – India, US, South Korea, Japan and the EU.
• Primary focus – To identify and mitigate the weaknesses in the bio-pharmaceutical supply chain through advanced manufacturing technologies and robust research and development (R&D) initiatives.
• Importance – It is a crucial step towards enhancing economic security and public health resilience on a global scale.

What are the key objectives of the Biopharmaceutical Alliance?

• Building a resilient supply chain – It involves ensuring the production of essential raw materials and ingredients is diversified and not overly concentrated in a few regions.
• Coordinating bio-policies and regulations – By harmonizing standards and procedures, it will facilitate smoother cross-border collaborations.
• It may also reduce bureaucratic hurdles that can impede the swift delivery of critical biopharmaceutical products.
• Supporting research and development – It places a strong emphasis on joint R&D efforts.
• By pooling resources and expertise, the member countries intend to accelerate innovation in the biopharmaceutical field.
• It also plans to ensure that new and effective treatments are developed and made accessible more rapidly.
• Creating a detailed supply chain map – A comprehensive pharmaceutical supply chain mapping will identify critical nodes and potential points of failure within the supply chain.
• This will enable the alliance to proactively address weakness and enhance the overall resilience.

What is Indian Pharmaceutical Alliance (IPA)?

• It is an association of 23 leading research-based pharmaceutical companies in India, committed to patient care globally.
• Formation – IPA began its journey in 1999 with six top drug makers - Cipla, Dr Reddy’s, Lupin, Piramal, Ranbaxy and Wockhardt - as its founding members.
• Aim – To create a collaborative environment for the Indian pharma industry to discover, develop and deliver quality-assured medicines equitably.

• Significance – It has evolved as the most potent voice for the Indian pharma industry, promoting high standards in pharmaceutical production and quality assurance.
• IPA companies collectively account for
  • 85% of the private sector investment in pharmaceutical R&D
  • 80% of India’s exports of drugs & pharmaceuticals
  • 62% of the price controlled medicines
  • 60% of the domestic market sales

References 

1. The Hindu | Biopharmaceutical Alliance
2. FDA| Biopharmaceuticals
3. IPA| Indian Pharmaceutical Alliance