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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.

Xbrane announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

The UK High Court rules filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from Roche/Genentech’s protection in the UK. These errors arose when a third party engaged by Roche/Genentech failed to pay the ...

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis.