Biosimilars on a roll: Biocon’s potential IPO; new launches by Fresenius, Pfizer

By PharmaCompass

2019-05-09

Impressions: 77 Article

There was a lot of news from the world of biosimilars. First, Fresenius Kabi announced it is launching its first biosimilar medicine in Germany — Idacio. The drug is a biosimilar of the world’s best-selling drug Humira and is available in the following administration options: pre-filled syringe, pre-filled pen and vial.

The launch follows marketing authorization granted by the European Commission (EC) to Idacio for all indications of Humira in the areas of rheumatology, gastroenterology and dermatology.

“The launch of Idacio in Germany is an important milestone for our company and for all patients who will now have an additional option for access to high-quality treatment,” Michael Schönhofen, President Pharmaceuticals and Devices Division of Fresenius Kabi, said.

Second, Pfizer is preparing for three biosimilar launches this year in the field of cancer-care — trastuzumab, rituximab and bevacizumab.

“Trastuzumab was already launched in the EU in the first quarter, and we look forward to the launch of trastuzumab in Japan in the third quarter,” Pfizer’s group president of biopharmaceuticals, Angela Hwang, told investors. “Rituximab will also be launched in Japan, and that will be in the fourth quarter.”

“Bevacizumab will be launched in both the US and Japan in the fourth quarter,” she revealed.

“We’ve seen some nice uptake in the supportive oncology portfolio that we launched late last year and we look forward to the oncology biosimilar portfolio contributing to our growth,” Hwang stated.

Since the start of this year, Pfizer has already boosted its oncology biosimilars portfolio by obtaining an authorization in the EU for Zirabev, a biosimilar to Avastin (bevacizumab) for treating multiple forms of advanced or metastatic cancer. And in the US, the FDA had approved Pfizer’s Trazimera (trastuzumab-qyyp) biosimilar to Herceptin in March as a treatment for certain forms of breast and gastric cancer.

“Revenues from our biosimilars portfolio grew 7 percent operationally in the quarter,” CEO Albert Bourla said.

Biocon Biologics IPO: Indian drugmaker Biocon Limited continued to show strong results in the fourth quarter, buoyed by momentum in its biologics business and robust growth in its research services segment. Chairperson and managing director Kiran Mazumdar-Shaw has said Biocon could spin-out its biologics division to raise funds for further biosimilar development.

During an investor call, Biocon said it is looking at consolidating its biosimilars business under Biocon Biologics India Limited. “And one of the potential options for our money raising is the IPO, and we can consider raising IPO at this entity level,” the company said.

Biocon’s biologics business grew 87 percent to US$ 64.6 million (INR 4.51 billion) in the fourth quarter of the financial year that ended in March 2019. Mazumdar-Shaw termed the year as a “landmark” year for the segment, as the revenues crossed US$ 200 million.

“Our biosimilar strategy has begun to deliver with the start of monetization of our biosimilars pipeline in the developed markets of the US and EU. The launch of biosimilar pegfilgrastim (marketed as Fulphila by Biocon’s partner Mylan NV) in the US and the ramp-up of sales of our biosimilar trastuzumab in emerging markets were the main contributors to this growth,” Mazumdar-Shaw said.

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