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On 16 April 2020, the Centre for Biosimilars published America’s Health Insurance Plans call for further action to address barriers to competition for biosimilars. This action includes shortening product exclusivity periods, creating a searchable Purple Book, introduc...

On 16 April 2020, Biocon announced it had received an Establishment Inspection Report (EIR) from the FDA for two biologics facilities in Bengaluru. Biocon expects that this EIR will allow for the filing of marketing authorisation applications for biosimilar products in seve...

MSD and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline ...

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections.

Significant biosimilar activities this week include

March 20 | BiosanaPharma released the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.
06 April 20 | The International Generic and Biosimilar Medicines Association (IGBA) calle...

NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.

Pfizer announces the FDA has approved Braftovi® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of BRAF600E-mutant metastatic colorectal cancer after prior therapy.

On 06 April 2020, the International Generic and Biosimilar Medicines Association (IGBA) called for urgent priority designation for medicines at custom controls for cargo and freight during the CoVid-19 pandemic. In particular, IGBA highlighted the need for ICU medicines and...

Significant biosimilar activities this week include

30 Mar 20 | Biocad announced it had received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.
30 Mar 20 | In response...

Pfizer announces EC approval of Ruxience® for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.