Biosimilar Regulatory Submission Updates: Europe, U.S., Japan, Canada

Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines.  In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights:

On June 1, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) provided positive opinions in favor of approval of Sandoz’s adalimumab biosimilar (under trade names Halimatoz, Hefiya and Hyrimoz, each having a different set of indications) and Pfizer’s trastuzumab biosimilar (Trazimera).

In a press release, Sandoz welcomed the CHMP opinion for its adalimumab biosimilar, which Sandoz states recommends approval “for treatment of all indications of its reference medicine [Humira®] including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.”  As we previously reported, the first adalimumab biosimilars are expected to hit European markets in October 2018.

A Pfizer press release similarly applauded the CHMP opinion for its biosimilar of Herceptin® (trastuzumab), which Pfizer states is its “fourth biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA.”

Also on June 1, Mabion announced that it submitted a Marketing Authorisation Application (MAA) to the EMA for MabionCD20, a proposed biosimilar of MabThera® (rituximab).  Mabion hailed the submission as “a historical achievement, because MabionCD20 is the first biotech drug to have been designed and developed from scratch in Poland by a team of Polish scientists.”  According to the press release, Mabion’s application included clinical trial results that “confirmed that the drug is equivalent to its reference drug” in patients with rheumatoid arthritis or non-Hodgkin’s lymphoma.  As we previously reported, in November 2016, Mabion entered into a long-term supply and commercialization agreement with Mylan that gave Mylan the exclusive right to commercialize Mabion’s rituximab biosimilar candidate in EU countries and non-EU Balkan states.

On May 31, Amgen announced that it received a Complete Response Letter from the U.S. FDA in response to its aBLA for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab).  Amgen states that it “will work closely with the FDA to bring this important medicine to patients in the U.S.” and that it does “not expect this to impact [its] U.S launch plan.”

On May 30, Mochida Pharmaceutical and AYUMI Pharmaceutical announced the launch of the first etanercept biosimilar in Japan.  According to the press release, Mochida developed the product based on a collaboration agreement with LG Chem, and Mochida supplies the product to AYUMI, which distributes the product in Japan.  As we previously reported, this biosimilar of Enbrel® was approved in Japan earlier this year.

On May 25, Lupin announced that the EMA has accepted Lupin’s MAA for a proposed biosimilar of Enbrel® (etanercept).  Lupin’s press release states that “Etanercept (YLB113) is the first biosimilar developed in-house by Lupin and this makes us the first Indian pharmaceutical company to file for a complex fusion protein like Etanercept in regulated markets.”  This news follows Lupin’s announcement earlier in May that YL Biologics, a joint venture between Lupin’s subsidiary Kyowa and Yoshindo, had submitted a New Drug Application for Marketing Authorization in Japan for this product.  According to Lupin, the most recent European “filing also opens up other key markets like Canada, Australia, the Middle East, South East Asia and Latin America,” for which “approvals … are expected within the next 12 to 18 months.”  Lupin further states that it “is on course with its plans for biosimilar Etanercept filing in the US and is targeting the same in FY 2019-20.”

On April 5, Health Canada approved Apotex-division Apobiologix’s Lapelga™, a biosimilar of Neulasta® (pegfilgrastim).  On June 1, a company press release declared the approval “a noteworthy success for Apobiologix as this is the first-ever pegfilgrastim biosimilar approved in any highly regulated market worldwide.”

Stay tuned to Big Molecule Watch for further biosimilar industry news.

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