Today, drugs are not only produced in chemistry laboratories, but also with the help of living cells, i.e. biotechnologically – so-called biopharmaceuticals. Animal cells, yeast or bacterial cultures, and – very rarely – plant cells are used. In contrast to chemical synthesis, biotechnology can also be used to produce highly complex active ingredients (such as … Biopharmaceuticals & Biosimilars
Products Rituximab is commercially available as a concentrate for the preparation of an infusion solution and as a solution for subcutaneous injection (MabThera, MabThera subcutaneous). It has been approved in many countries and in the United States since 1997 and in the EU since 1998. Biosimilars are available in some countries, including many (2018, Rixathon, … Rituximab
Products Infliximab is commercially available as a powder for a concentrate for the preparation of an infusion solution (Remicade, biosimilars: Remsima, Inflectra). It has been approved in many countries since 1999. Biosimilars were released in 2015. Structure and properties Infliximab is a chimeric human murine IgG1κ monoclonal antibody with a molecular mass of 149.1 kDa … Infliximab: Drug Effects, Side Effects, Dosage and Uses
Products Enoxaparin is commercially available as a solution for injection (Clexane). It has been approved in many countries since 1988. Biosimilars were released in the EU in 2016 and in many countries in 2020 (Inhixa). Structure and properties Enoxaparin is present in the drug as enoxaparin sodium, the sodium salt of a low-molecular-weight heparin (LMWH) … Enoxaparin
Products Somatropin is commercially available as an injectable from several manufacturers. Recombinant growth hormone has been available since the late 1980s. Biosimilars are approved in some countries. Structure and properties Somatropin is a recombinant polypeptide hormone with a molecular mass of 22 kDa, consisting of 191 amino acids. It corresponds to human growth hormone from … Somatropin
Products TNF-α inhibitors are commercially available as injectable and infusion preparations. Infliximab (Remicade) was the first agent from this group to be approved in 1998, and in many countries in 1999. Biosimilars of some representatives are now available. Others will follow in the next few years. This article refers to biologics. Small molecules can also … TNF-Α Inhibitors
Products Filgrastim is commercially available as a solution for injection in vials and prefilled syringes (Neupogen, biosimilars). It has been approved in many countries since 1991. Structure and properties Filgrastim is a protein of 175 amino acids produced by biotechnology. The sequence corresponds to human granulocyte colony-stimulating factor (G-CSF, Mr = 18,800 Da) with the … Filgrastim
Products Trastuzumab is commercially available as a lyophilizate for preparation of an infusion concentrate (Herceptin, biosimilars). It has been approved in many countries since 1999 (US: 1998, EU: 2000). In 2016, an additional solution for subcutaneous injection for breast cancer therapy was released in many countries (Herceptin subcutaneous). It was available earlier in other countries. … Trastuzumab
Products Pegfilgrastim is commercially available as a solution for injection in the form of prefilled syringes (Neulasta). It has been approved in many countries since 2003. Biosimilars have been approved. Structure and properties Pegfilgrastim is a conjugate of filgrastim with a single 20-kDa polyethylene glycol (PEG) molecule. Filgrastim is a protein of 175 amino acids … Pegfilgrastim
Products Low-molecular-weight heparins are commercially available as injectable solutions, in the form of prefilled syringes, ampoules, and lancing ampoules. The active ingredients now commonly used in many countries were first approved in the late 1980s. Biosimilars are available in some countries. The active ingredients are abbreviated in English with the acronym LMWH (low molecular weight … Low-Molecular-Weight Heparins
Products Follitropin alfa is commercially available as an injectable. It has been approved in many countries since 1995. Biosimilars are approved in some countries (Switzerland: Ovaleap, 2018). Structure and properties Follitropin alfa is a follicle-stimulating hormone (FSH) produced by biotechnological methods. It is a heterodimer and consists of two distinct glycoproteins, the α-subunit (92 amino … Follitropin Alfa
Products Etanercept is commercially available as a solution for injection (Enbrel, biosimilars). It has been approved in many countries since 2000. The biosimilars Benepali and Erlezi were approved in many countries in 2018. Structure and properties Etanercept is a dimeric fusion protein composed of the extracellular ligand-binding domain of TNF receptor-2 and the Fc domain … Etanercept
