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The World in Brief (July 2nd Edition)

The World in Brief This e-newsletter is provided courtesy of Reed CNY Business Law, P.C.

Bio-Pharma: US Court Approves Biosimilar Marketing A federal appeals court has overruled an attempt by Genentech to stop Amgen from selling a bevacizumab biosimilar (Mvasi) in the United States. Mvasi had $108 million in sales in the United States during the first quarter of this year, and its share of the US market for bevacizumab is 33%. Global sales of Avastin topped $7 billion last year, fueled by growth in China. Genentech alleged changes made to Amgen’s FDA application were significant enough to require another 180-day ‘notice of intent’ to Genentech. The court disagreed, saying the purpose of the notice was to inform the BLA holder that someone is coming in with a biosimilar; Genentech got that notice, even if it was before there were changes. But the court went on to give some clarity on the issue of amendments to such filings. This interpretation for situations not part of the current lawsuit makes this ‘an activist court.’ Reed Business Law assists clients not only in understanding the statutes and regulations regarding the U.S. healthcare industry, but also with interpretation of the court decisions involving those laws. 미연방항소법원은 글로벌제약사 Genetech 이 Amgen 에 대해 청구한 소송을 기각하는 판결을 내렸습니다. Amgen 의 바이오시밀러, bevacizumab (Mvasi)는 올해 1 분기에 미국에서 33%의 점유율을 올리며 1 억 8 천만불을 판매했습니다. Genetech 기준제품 Avastin은 중국에서의 판매증가에 힘입어 70 억달러의 매출을 기록했습니다. Genetech은 Amgen의 FDA 제품승인중에 신청서를 변경하였기 때문에 Genetech 에 변경고지를 하였지만, 본신청절차에 오류가 있다고 주장했습니다. 반면에 항소법원은 고지의 목적은 바이오시밀러 제조사가 해당제품의 원 BLA (생물의약품허가신청) 승인자에게 바이오시밀러의 FDA 신청을 알리기 위한것이므로 신청서 변경을 고지하지않은 것은 위해가 없다고 하였습니다. 판결은 미국법원이 바이오시밀러제조와 FDA 신청에 적극적으로 관여하고 있다는 것을 보여주고있습니다.

International Business: Why the United States-Mexico-Canada Agreement is Important to FDA

The United States-Mexico-Canada Agreement (USMCA) became effective as of July 1, 2020. The USMCA updates and supersedes the 25-year-old North American Free Trade Agreement (NAFTA). Work on the new agreement took several years, had to be approved by both houses of Congress and required that the three countries certify their compliance with various measures in the agreement. There are two key reasons why FDA follows trade policy: i) to protect FDA regulations and authorities and ii) to use trade agreements as a vehicle to advance public health. From FDA’s point of view, the USMCA aligns regulatory standards with agency practices, betters the quality of products available to American consumers, and levels the playing field for American businesses. This agreement is profound and should be interesting to any company in any industry interested in operating in North America. Reed Business Law will release a special article regarding USMCA.

7 월 1 일 부터 미국-캐나다-멕시코협정이 발효되어 의약품관리규정에도 변화가 일어나고있습니다. 본 협정의 체결과 발표를 위해 미국의 상원과 하원은 캐나다, 멕시코와 수년간 협상을 통해 지난 25 년 동안 준수했던 NAFTA 의 내용을 업데이트하고 해당 협정으로 대체하게되었습니다. 미 FDA 가 중점을 두고 있는 부분은 두가지입니다. 첫째는 FDA 의 기존 법률과 규칙을 보호하는 것이고, 둘째는 본 협정을 잘이용해서 미국 보건의 향상을 도모하는 것입니다. FDA 의 관점은 본 협정을 통해 FDA 의 규정을 유지하며, 미국 소비자들에게 좋은 제품을 제공하며, 비지니스에 도움이 되기를 바라는 것입니다. 저희 로펌은 미국-캐나다-멕시코협정의 의약품관련 특벌사설을 곧 배포할 예정입니다.

Bio-Pharma: Complex World of U.S. Biosimilar Approvals

Even though it’s been ten years since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), biosimilar applicants face an uneasy reality when they prepare an ‘abbreviated Biologics License Application’ (aBLA). There are a myriad of factors toweigh, and eachbiosimilar applicant shouldcarefully consider the option that best fits its biosimilar development and marketing strategy. For example, should the applicant submit notice to the reference product sponsor (RPS), the original biologic license holder, of its aBLA and allow the RPS to tell the biosimilar applicant of all potential patent infringements? Or should the biosimilar applicant simply submit the aBLA to the FDA and allow the RPS pursue infringement claims at a later date? The recent opinion from the Federal Circuit in Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC (May 8, 2020) highlights a potential benefit of participating in the patent dance, - an early resolution based on an issue of law. Eagle comes to us from the Hatch-Waxman (drugs, not biologics) world, but the issue and outcome were very similar to a biosimilar case, Amgen Inc. v. Coherus Biosciences Inc., (Fed. Cir. 2019). In both instances, judges in the patent-savvy District of Delaware granted defendants’ Rule 12 motions early in the litigation, limiting the plaintiffs’ abilities to allege infringement under the doctrine of equivalents, specifically because the defendant/biosimilar developers had shared their aBLAs with the plaintiff/RPSs. And in both instances the dismissals were affirmed by the Federal Circuit. However, other court cases alleging patent infringement have been decided in the defendant/biosimilar developer’s favor when the aBLA has not been shared with the RPS, making this ‘patent dance’ very difficult for foreign-based companies looking to market biosimilars in the U.S. Even US companies and the attorneys advising them are not sure what the right approach is. Reed Business Law consults with foreign manufacturers to interpret the most recent court cases so that the clients can understand how best to come into U.S. biosimilar market.

바이오의약품 약가경쟁및 혁신법이 발표된지 10 년이 경과되었지만, 바이오시밀러 제조사들은 바이오의약품 품목허가신청을 준비할때마다 어려움을 겪고있습니다. 기준제품제조사에게 또는 바이오의약품 품목허가승인자에게 고지를 언제해야할지, 또는 먼저 FDA 에 신청을 한후에 후일에 고지를 해야할지등, 여러가지 고민해야 될것이 많습니다. 최근 연방순회법원의 케이스인, Eagle Phamaceuticals Inc. v. Slayback Pharma LLC 를 살펴보면 본 사안은 Hatch-Waxman 의 기준 (제약)을 따르다가 판결기준은 biosimilar 케이스, Amgen Incv. Coherus Biosciences Inc.와 비슷한 방향으로 내려졌습니다. 두 판결모두, 델라웨어법원의 융통성있는 방침에 따라 균등론에 의거해 피고에게 Rule 12 motion 이 받아들여져 특허침해가 없다는 취지로 판결이 내려졌습니다. 그러나 타법원의 판결은 Eagle v. Slayback 의 판결기준과 다르게 내려져, 바이오시밀러 제조사들에게 혼란을 주고있습니다.

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