Alvotech S.A., a Danish biopharmaceutical company listed on the NASDAQ stock exchange.
Alvotech is not involved in physical products like medical equipment or food ingredients. They are a biosimilar company, which means they develop and manufacture medicines closely similar to biological drugs already on the market, but at lower prices.
Recently, Alvotech released a press that its clinical study results demonstrated therapeutic equivalence between biosimilar candidate AVT06 and reference product Evlea(R) (aflibercept). Eylea is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. In the last twelve months before September 30, 2023, cumulative global sales of Eylea were about US$9.4 billion.
a biosimilar is a specific type of medicine:
- Highly similar: It's a drug created to be almost identical in structure and function to an already existing biological medicine (also called a biologic). These original biologics are often complex medications derived from living organisms, like proteins or antibodies.
- Lower cost: Compared to the original biologic, a biosimilar typically comes at a significantly lower price. This makes them more accessible to a wider range of patients and can ultimately reduce healthcare costs.
- Not generic: It's important to note that biosimilars are not the same as generic drugs. Generic drugs are chemically identical copies of existing, branded drugs and typically require less rigorous development and testing. Biosimilars, due to the complex nature of biologics, need extensive testing and comparison to ensure their safety and efficacy are comparable to the original drug.
- Approved by regulators: Before reaching patients, biosimilars must undergo rigorous approval processes by regulatory agencies like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This ensures they meet high standards of quality, safety, and effectiveness.
These biosimilars typically target chronic diseases like psoriasis, Crohn's disease, and rheumatoid arthritis.
Here are some of Alvotech's key products (biosimilars):
- AVT02: biosimilar to Humira (adalimumab) used for treating various inflammatory diseases.
- AVT03: biosimilar to Enbrel (etanercept) used for similar indications as AVT02.
- AVT04: biosimilar to Stelara (ustekinumab) used for treating psoriasis and Crohn's disease.
- AVT05: biosimilar to Remicade (infliximab) also used for various inflammatory diseases.
- AVT06: biosimilar to Avastin (bevacizumab) used for treating cancer.
These are just some of their leading products, and Alvotech has a pipeline of additional biosimilars in development.
