Biosimilars in Europe: A Pathway to Affordable Healthcare?

Biosimilars are now continuously transforming the visage of the EU healthcare utility as these are cheaper imitations of the patent-driven biologic medicines. An opportunity through which biosimilars could pose a solution to sustainable, affordable health care in the European region, hence being able to impact the lives of many patients and health care facilities.

Introduction

Biosimilars are those that have a relationship with biologic drugs whether the ones that have gained the marketing authorization or not and biosimilars have importance in Europe. They are products that have been developed using as base natural resources and are used in treatment of ailments like cancer, rheumatoid arthritis and diabetes. However, biologic drugs are often expensive and put pressure on the healthcare system and thereby reduces the accessible to patients. Thus promoting health care by presenting an equally effective, inexpensive version of the drugs through biosimilars.

What Are Biosimilars?

On the other hand biosimilar is a biologic medical product that is strongly resonant to a first biologic product known as the reference product which has been licensed by the regulating agencies such as the EMA. Though as stated ‘identicals’ biologics are not being termed in simple terms, yet biosimilars were confirmed to be clinically similar for safety, efficacy or quality to original reference product.

The Need for Affordable Healthcare in Europe

As personified in the trend chart, cost of care has risen mainly due to the increasing use of technology in the health sector and costly biologic drugs. All these occur at a time when Europe’s population is aging and more people are suffering from chronic diseases, meaning that there is need for healthcare cost to be contained without necessarily affecting the quality of care.

Affordable Healthcare in Europe

Here, biosimilars can be utilized to introduce a kind of competition that brings about the reduction of the prices of drugs hence enhancing their accessibility.

Regulatory Pathways for Biosimilars in Europe

Europe has been more active in developing biosimilar because EMA begun the approval of biosimilar from the year 2006. The regulatory guidelines on biosimilars approval in Europe entails several documentations in order to be granted approval to market the biosimilar in the market stating that the proposed biosimilar matches the reference biosimilar in terms of quality, safety and efficacy. To prove the seniority of monopolies, manufacturers have to show that minor distinctions of the biosimilar as compared to the reference product could not have an impact on the drug’s effectiveness in treatment. This affords the patients the benefits of the several biologics that are of similar effectiveness to the original treatments.

Benefits of Biosimilars

The introduction of biosimilars in Europe brings several benefits:

Cost Savings: Biosimilars are much cheaper to manufacture than original biologics and therefore cheaper to purchase which makes savings for the health care systems. This makes it possible in healthcare to take care of other expenses, development of new health care treatments or growing health care services to attend client’s needs.

Increased Access: Biosimilar, being cheaper than branded biologics, brings formerly unaffordable treatment to a larger amount of patients and thus benefits health of the population.

Market Competition: Competition resulting from the entry of biosimilars makes pharmaceutical firms compete on prices hence bringing down the overall cost of healthcare including prices of original biologics.

Challenges to Adoption

Despite the benefits, the widespread adoption of biosimilars in Europe faces several challenges:

Physician and Patient Acceptance: This could be for two reasons: some of the health professional and or patients have not used biosimilar before but are familiar with the biologic, and therefore would not be willing to switch to the cheaper product knowing fully well that efficacy and safety are the same for both products. These concerns are noticed and focusing on education and awareness is the key to overcome them.

Future of Biosimilars in Europe

Regulatory Hurdles: Even though the EMA has provided very clear recommendations for biosimilars there is added complexity in the approval process meaning that much research and clinical trials have to be conducted to verify on quality and effectiveness of biosimilars. This can stifle the entry of new biosimilars in the market for instance in the USA.

The Future of Biosimilars in Europe

In total, the orientation of further development for biosimilars in Europe can be considered quite optimistic. Given many biologic drugs are now entering the expiry of their patent protection, the number of biosimilars is expected to increase in the future years. It may eventually improve the level of competition cut price again and increase the availability of treatments for the patient in the EU. There are also discussions on how to increase use of biosimilars through increasing usage of incentives to doctors and creating awareness through awareness creation.

Conclusion:

Offering biosimilars is therefore the right chance for the Europe to get affordable health care. When developed, the latter lower-priced products may help to decrease direct healthcare costs, increase patient access to life-saving therapies, and enhance the long-term viability of healthcare systems. Increasing availability of the biosimilars will only mean increased access to high quality health to all the citizens of Europe.

Visit now: https://www.pharmafocuseurope.com/articles/biosimilars-in-europe-a-pathway-to-affordable-healthcare