Seven biotech IPOs ready to roll; Celltrion's Herceptin biosim gets second review at FDA
→ Renaissance Capital is tracking 7 new biotech IPOs this week. The lineup includes Magenta, Avrobio and Autolus, all high-profile ventures that will be testing the market again.
→ Forty Seven set terms on its IPO, looking to sell 6.7 million shares at $14 to $16 apiece.
→ South Korea’s Celltrion is finally getting back on track with the US regulatory process for Herzuma, its biosimilar for Herceptin. The company had filed for resubmission in May after receiving a complete response letter in April; now that the review is resumed, a decision is expected within six months. The reversal is notable given that the FDA had, just days ago, snubbed a copycat from Amgen/Allergan — another rival vying for Roche’s blockbuster cancer drug, which brought in $7 billion last year. As is the case for Amgen/Allergan’s and Pfizer’s Herceptin biosims, Herzuma is already approved in Europe, where regulators are quicker to give OKs in this category.
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