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As soon as patent expiries, biopharmaceuticals can be produced and marketed by manufacturers other than the originator. These new biotechnology medicines are known as “biosimilars” or “similar biological medicinal products” because they are claimed to be highly similar to an already approved reference product.
According to the European regulatory framework, biosimilarity means that the biological product is highly similar to the licensed reference biological product notwithstanding minor differences in clinically inactive components; and that there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.
In 2006, the first biosimilars have received European regulatory approval, therefore becoming a commercial reality in European markets.
Nutraceuticals and Medicinal Plants
Historically, mankind is closely linked with the use of medicinal plants to cure illnesses and ailments. Today, the evidence shows that synthetic drugs cause negative side effects, stimulating the consumption of natural products and that includes nutraceuticals.
Regarding nutraceuticals and medicinal plants, they are increasingly seen as part of a healthier and more sustainable lifestyle, in line with a trend on health products based more on prevention rather than cure.
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