BioBlast w/e 21 Apr 23

20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent® (dupilumab) in children > 6 months

Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® (dupilumab) as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or not advisable.

This comes weeks after Sanofi/Regeneron announced European Commission approval of Dupixent® on 21 March 2023 for the same age group.

20 April 2023 | Samsung Bioepis to present new data on aflibercept (Eylea®) biosimilar

Samsung Bioepis announced that it will present new data on its SB15 (proposed aflibercept biosimilar) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on 23 and 24 April 2023, including 56-week results from its Ph III trials.

Samsung Bioepis and Biogen announced a partnership for the commercialisation of aflibercept and ranibizumab biosimilars in November 2019.

19 April 2023 | US | FDA grants Priority Review to sNDA of Lonsurf® (trifluridine/tipiracil) with Avastin® (bevacizumab) for mCRC

Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC).  The sNDA is based on results of a phase III clinical trial which combined Lonsurf® with Genentech’s Avastin® (bevacizumab), which saw improved survival and progression-free survival over Lonsurf® alone.  The FDA expects to decide on the sNDA by 13 August 2023.

Last year Genentech and Samsung Bioepis settled their US BPCIA Avastin® bevacizumab patent dispute.

19 April 2023 | US | FDA approves Genentech/Roche’s Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) for DLBCL

Genentech and Roche announced that the FDA approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified or high-grade B-cell lymphoma, and who have an International Prognostic Index score of two or greater.  This approval converts the FDA’s previous accelerated approval of Polivy® in combination with bendamustine and Rituxan® for relapsed or refractory DLBCL into a regular approval.

We recently reported that Dr. Reddy’s was preparing to file BLA/MAA dossiers for rituximab biosimilar against Rituxan®.

18 April 2023 | US | Samsung Bioepis predicts biosimilars will save US$181B in five years in the US

Samsung Bioepis released its first US Biosimilar Market Report which found that biosimilars will save the US healthcare system $181B in the next five years.  The report will be published each quarter after the Center of Medicare, Medicaid Services publishes new data.  Key findings from the report include:

• On average, biosimilars gained 53% market share in the three years after their initial launch. This was influenced by the faster acceptance (75%) for oncology compared to other therapeutic areas (25%) and for pegfilgrastim compared to other molecules
• Average sales prices declined 41% on average three years after first biosimilar launch. The prices for oncology biosimilars experienced the steepest decline (each dropping >50% in the first three years after biosimilar launch)
• Unbranded insulin glargines are discounted by up to 66% compared to Lantus® (Sanofi)
• As of Q4 2022 the biosimilar share of the trastuzumab market has reached 82%

17 April 2023 | US | Celltrion launches Vegzelma® (bevacizumab) biosimilar to Genentech’s Avastin®

The Korean Biomedical Review reported that Celltrion has launched Vegzelma®,  biosimilar to Genentech’s Avastin® (bevacizumab), in the US .

Celltrion received FDA approval for Vegzelma® in September 2022 for the treatment of six types of cancer.

17 April 2023 | EU | Approval Alert: EC approves AbbVie’s Rinvoq® (upadacitinib) for Crohn’s disease

AbbVie announced that the European Commission has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or areintolerant to either conventional therapies or biologic agents.  According to Abbvie, this is the seventh approved indication for Rinvoq® in the EU and is the only oral Janus Kinase inhibitor approved to treat adult patients with moderately to severely active Crohn’s disease.

The CHMP gave a positive opinion for Rinvoq® for the above indication on 27 February 2023.

14 April 2023 | Court denies Mylan motion seeking to narrow scope of Eylea® biosimilar infringement proceedings

The District Court of West Virginia denied Mylan’s emergency motion seeking orders which would require Regeneron to immediately narrow the scope of its infringement proceedings to 12 claims of 3 patents. As it currently stands, Regeneron is required to narrow the scope of the proceedings within seven days of the court making its Markman order, or seven days after the close of fact discovery, whatever is later.  The Court found that Mylan had not shown good cause for an emergency order status or a modification of the scheduling order.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®, and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

30 March 2023 | Takeda study finds vedolizumab (Entyvio®) more effective than placebo inducing remission of chronic pouchitis after undergoing IPAA for UC

A Takeda study published in the New England Journal of Medicine found that vedolizumab was more effective than a placebo at inducing remission in patients with chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis (UC).  31% of patients who received Takeda’s Entyvio®/Kynteles®/MLN0002 (vedolizumab) were in remission after 14 weeks, compared to 10% who received the placebo.

In March 2023, Takeda received Japanese approval for subcutaneous Entyvio® as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.