On biosimilar medicines

Biosimilar pharmaceuticals are biological medicines that are, or will soon be, no longer protected by patents. Biological medicines (also called „biopharmaceuticals”) are biotechnology-derived medicines whose active ingredient is produced from living organisms, such as plant or animal cells, bacteria, viruses and yeast.

Biosimilars are as safe and effective as the originator biological medicine. They follow the specific provisions of EU legislation which include defined high standards of quality, safety and efficacy. Standards of the EU Good Manufacturing Practice (GMP) apply to the manufacture of biosimilar medicinal products in the same way as for any other biological medicinal product. Compliance with the EU GMP Guidelines is verified during routine GMP inspections by the EU national competent authorities.

Biosimilar medicinal products have been used safely in clinical practice in the European Union since 2006 and their market share has been growing at different rates across both EU Member States and product categories.

Biosimilar medicinal products may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights. The availability of biosimilar medicinal products enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of EU healthcare systems. Thus, their availability offers potential economic benefit to EU healthcare systems while addressing the issue of new treatment options brought about by advances in medical science.

For further information, please access the web page on „Information on Biosimilar medicines” of the Medicines for Europe Asociation’s webpage.

Biosimilar medicines

Find out what biosimilar medicines are:


1. What are biosimilar medicines?

Biosimilar pharmaceuticals are biological medicines that are, or will soon be, no longer protected by patents. As with all other medicines, biological medicines become open to development and manufacture by other companies after their patent expires. The development of biosimilar medicines ensures continued patient access to safe, effective, and more affordable biopharmaceuticals.

2. What is the difference between biosimilar medicines and conventional medicines?

Biosimilar pharmaceuticals are biological medicines, which means that medicines whose active ingredient is produced from living organisms, such as plant or animal cells, bacteria, viruses and yeast. Conventional medicines are typically manufactured by a process called chemical synthesis, whereas most biological medicines are made from living organisms such as genetically modified cells.

3. Do biosimilar medicines have the same quality as the originator?

Yes. Biosimilar medicines are manufactured according to the latest state-of-the-art technology, ensuring the highest quality standards available. This approach ensures that the biosimilar product matches its reference product in terms of quality, efficacy and safety. Both originator reference products and biosimilar medicines are made under carefully controlled conditions to ensure the products are consistent and of the required quality. This is known as Good Manufacturing Practice (GMP). In the European Union, GMP inspections for all biopharmaceuticals — originator reference products and biosimilar medicines — are coordinated by the EMA and performed by the National Regulatory Agencies.

4. How is APMGR involved with biosimilar medicines?

The Association for Generic Medicine Producers (APMGR), the official representative body of the generic and biosimilar medicines industry, takes an active interest in all issues related to medicinal products, including medicines derived from biotechnology. Several member companies of APMGR are biotechnology companies or companies with biotechnology business units. APMGR supports companies developing biosimilar products by ensuring full market access and a favorable regulatory landscape for biosimilars in Romania and, more generally, in Europe as this will allow patients to gain access to more affordable high quality treatment.

5. Why is important to introduce biosimilar medicines?

On average, biopharmaceuticals cost much more per patient than conventional pharmaceuticals and their use is growing at a much higher growth rate than that of the overall pharmaceutical market. Many patients, however, can’t benefit from these medicines as they don’t have access to them. It is therefore critical to maximize patient access to cost effective biopharmaceuticals — and this means a rapid introduction of biosimilar medicines as soon as patents expire

6. Where is Europe now regarding biosimilar medicines?

The necessary legal framework for biosimilar medicines was adopted in the EU on 31 March 2004 and the first biosimilar medicines were approved by the European Commission in April 2006. All EU approved biosimilars products undergo the same rigorous scientific assessment at the European Medicines Agency (EMA) and its committees like any other biological medicine. Following the assessment, the Agency confirms that each of them „has been compared to and matches the reference medicine in terms of quality (how it is made), safety (for example the side effects that can occur when receiving treatment are similar), and effectiveness.” Guidance on risk management systems assures safe market entry and post-marketing monitoring of these medicines.

7. Who verifies the quality, safety and efficiency of a generic medicine?

Biotechnology medicines, including biosimilar biotechnology-derived medicines, are assessed by the European Medicines Agency in London (EMA), which constitutes the scientific body of the European Commission responsible for the evaluation of medicines. They are approved by the European Commission based on the positive scientific opinion issued by the EMA and its main expert committee the CHMP (Committee on Human Medicinal Products). When the EMA assesses data for a biosimilar medicine, the scientific principles for ensuring product quality, safety and efficacy are identical to those applied to the originator reference medicine with which comparability is demonstrated. In addition to the quality data required for all biotechnology products, the companies involved in the developing of biosimilar medicines must additionally submit „comparability data”. Manufacturers must characterize, in parallel, both their biosimilar product and the originator reference product. They must demonstrate, with a high degree of certainty, that the quality of the biosimilar medicine is highly similar to the originator/reference medicinal product. A comparability programme is clearly defined and agreed upon in advance with the EMA, who defines the set of non-clinical and clinical data that are necessary to sufficiently demonstrate biosimilarity. The extent of this data varies according to the type and complexity of the medicine involved. Each individual biosimilar medicine is assessed on a case-by-case basis.

8. What cost savings will biosimilar medicines bring to healthcare systems?

The improved affordability of healthcare that could result from the use of biosimilar medicines is real. In Germany, for example, the EPO biosimilar introduction resulted in EUR 60m annual savings (-17,3%) in the first year of the market. It has been estimated that biosimilars in Germany alone could contribute to 1 billion EUR annual savings from 2017. By 2020 the savings through biosimilars would be more than 8 billion EUR.

9. How is the landscape evolving for biosimilar medicines?

2013-2017 will see many further developments in relation to biosimilar medicines because the patent protection on many originator reference biotech products has expired already, and many more will expire over the next few years. As a result it is expected that a growing number of biosimilar products will be available on the market in the not too distant future.