The primary safety concern for biosimilar agents is their potential immunogenicity. Using biopharmaceuticals to replace endogenous proteins that may be present at insufficient concentrations carries the serious risk of stimulating the immune system to develop anti-product antibodies (Abs), which may cross-react with endogenous protein.
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
- Relevance of NTI to the treatment of epilepsy
- What is the meaning of a narrow therapeutic index?
- Canada approves etanercept biosimilar Rymti
- Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved
- Advances for Alvotech’s partnerships in Japan, Canada and Switzerland
- Progress for Lucentis (ranibizumab) biosimilars in Europe and the US
- AVT02 biosimilarity with Humira proved in chronic plaque psoriasis treatment
- Investigating biosimilar product drift and divergence
- Biosimilars, are they comparable to their reference counterparts?
- The cost savings of non-medical switching in dermatology
- MORE EDITORIAL SECTIONS