Teva gets EU nod for Neulasta ‘biobetter’

Teva has chalked up a milestone in its branded products business after winning EU approval for Lonquex, a white blood cell stimulator that will compete with Amgen’s blockbuster Neulasta brand.

The Israeli drugmaker said the European Medicines Agency (EMA) approved Lonquex (lipegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy for cancer.

Lonquex will compete in the marketplace with Neulasta (pegfilgrastim) and like its rival is dosed as a single subcutaneous injection once per chemotherapy cycle.

Teva’s drug is glycopegylated form of granulocyte colony stimulating factor (G-CSF), a cytokine that regulates the production and release of functional neutrophils from the bone marrow.

Glycopegylation differs from traditional pegylation in that it adds polymer chains to the active protein that are distant from the active site, which should in theory prevent variations in the activity of the drug molecule and increase its structural homogeneity.

Teva refers to Lonquex as a ‘biobetter’, although in trials Lonquex was shown only to be non-inferior to Neulasta, with no evidence as yet that it has any advantages over Amgen’s drug.
Nevertheless, the approval gives Teva another weapon in its arsenal as it competes against Amgen’s white cell stimulator franchise, which along with Neulasta also includes Amgen’s short-acting G-CSF product Neupogen (filgrastim).

Teva already markets a biosimilar version of Neupogen in Europe, alongside other biosimilars from Sandoz and Hospira, but with Lonquex approved now becomes the first company that can compete across the board with Amgen’s franchise, which collectively posted $5.35 billion in sales last year. The bulk of that total – some $4.1bn – was garnered by Neulasta.

The company’s chief executive Jeremy Levin said earlier this year that the company intends to launch biosimilar filgrastim in the US before the end of 2013, with lipegfilgrastim set to reach the US market in 2014. Meanwhile, Sandoz has a biosimilar version of Neulasta in phase III testing that could also be on the market next year.

“This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer,” commented the division’s chief executive Rob Koremans.

Other biobetters in Teva’s pipeline include an albumin-fused version of G-CSF called balugrastim that is ready for submission in the US and a long-acting human growth hormone product which is in Phase I testing.

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