# Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA
## 8 Conclusions and Future Prospects  
Biological medicines are innovative products used to treat complex and chronic diseases. These products are produced from living organisms using advanced biotechnology techniques. They are generally made of proteins, which have a complex molecular structure and some intrinsic variability associated. Their cost and production time is high, leading to a demand for more accessible alternatives equally safe and effective. Thus, with the expiry of the biological medicines' patents, a new class of medicines has begun to emerge on the pharmaceutical market: biosimilar medicines. These products are well known for being \"copies\" of an already approved biological medicine. The biosimilar producer must develop its own process, which can lead to some differences between the biosimilar and its reference biological medicine. These differences are acceptable as long as comparability studies demonstrate the biosimilar has no clinically significant differences from its reference. In the past years, the pharmaceutical market has undergone a major revolution with the appearance of biosimilar medicines. These products have increased patient access to biological products with the same safety, efficacy and quality of their reference medicine, but at a considerably reduced cost. Due to the unique characteristics of biosimilars, specific guidelines were created by regulatory authorities to assist manufacturers developing medicines that meet strict safety, efficacy and quality criteria. Several regulatory authorities around the world have defined their own guidelines, as well as the review and approval process for this type of product, fostering the production of high-quality biosimilars, facilitating the regulatory approval process and speeding up their entry into the pharmaceutical market. The appearance of biosimilar medicines has brought numerous benefits. Due to their lower cost, biosimilars increase patient access to biological medicines and offer doctors and patients more treatment options, being a useful alternative when the reference biological is not available or is discontinued, ensuring continuity of treatment. Furthermore, these medicines have created competition in the pharmaceutical market, which can promote price reductions and improve the consequent accessibility of treatments, stimulating innovation, as pharmaceutical companies are encouraged to develop new therapies and improve production processes to remain competitive. Finally, for healthcare systems, the savings generated using biosimilars can be redirected to other areas, such as the research and development of new treatments, improvements in health infrastructure and the creation of education programs. However, biosimilars still have some obstacles to overcome. There is a lack of information concerning these products and many healthcare professionals and patients are still not completely familiar with these products and their advantages. This can cause hesitation when it comes to prescribing a biosimilar instead of an original biological product. Furthermore, although the approval processes for biosimilars have been well established, there are still challenges regarding harmonization of regulatory requirements. Improving and  
Figure 9: Currently available Humira® biosimilars (* Official logo not available). simplifying approval processes or even creating a single regulatory pathway that ensures the safety and efficacy of these complex products would accelerate and facilitate the entry of more biosimilars into the market worldwide and enhance competition. In a near future, the pharmaceutical market will face a \"biosimilar gap\", since the patents of some biological products are about to expire and no corresponding biosimilars are available. This represents a great opportunity for manufacturers, and it is therefore expected that several companies will start producing biosimilar medicines. The creation of strategic partnerships between pharmaceutical companies is also expected, to speed up the development of these products.