Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.
As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.
The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.
This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.
The critical importance of biologic drugs:
The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:
Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.
Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.
Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.
Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.
Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.
It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.” This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.
Patient access to original biologic drugs in India faces several key barriers:
Patient access to original biologic drugs in India faces several key barriers, including:
1. Cost and Affordability:
- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.
- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.
2. Limited Healthcare Coverage:
- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.
- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.
3. Regulatory Barriers:
- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.
- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.
4. Limited Local Manufacturing:
- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.
- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.
5. Physician Awareness and Education:
- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.
- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.
6. Patient Education and Understanding:
- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.
- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.
These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.
Healthcare impact of inadequate access and availability of biologic drugs in India:
The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts:
Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.
Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.
Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.
Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.
Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.
Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.
Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.
Increasing need for biosimilar drugs in India and issues involved:
From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.
However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.
Some global synergy is evident in this critical healthcare space:
The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:
- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India.
- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.
- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.
These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.
Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.