Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year:

  1. USPTO Outlines New Initiatives Regarding Drug Pricing

In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several initiatives designed in collaboration with the FDA to “get[] generic, biosimilars and more affordable versions of [] drugs into the hands of Americans.”  The letter outlines five initiatives to strengthen the patent system including: (1) enhancing collaboration between the government agencies such as between the USPTO and the FDA; (2) improving procedures at the USPTO to ensure that it “issues robust and reliable patents”; (3) improving the process for challenging issued patents; (4) improving public participation; and (5) evaluating new proposals that incentivize drug development.

To enhance collaboration between the USPTO and the FDA, the USPTO plans to, among other objectives, (a) provide patent examiners with training on publicly available FDA resources that can be used for prior art searches; (b) identify ways to ensure consistency in representations made to the USPTO and the FDA, for example by requiring applicants to submit to the USPTO any information submitted to other agencies; and (c) develop procedures for notifying the FDA of AIA proceedings regarding Orange Book and Purple Book-listed patents.

To ensure that the USPTO “issues robust and reliable patents,” the USPTO plans to (a) increase the time examiners may use to examine patent applications, especially where there are large numbers of related co-pending applications; (b) ensure that examiners know of relevant prior art and statements from PTAB proceedings that may impact examination of patent applications before them; (c) improve access to references identified in Information Disclosure Statements; (d) increase involvement of Quality Assurance specialists in continuation applications and in reviewing declaratory evidence provided by Applicants; (e) revisit whether it is good public policy to allow the use of terminal disclaimers to overcome obviousness-type double patenting rejections; and (f) consider ways to increase the use of third-party submissions in patent examination proceedings.

To improve the process for challenging issued patents, the USPTO plans to: (a) apply additional scrutiny of continuation applications and applications where declarations are used to support patentability; (b) allow third party input in PTAB proceedings; and (c) weigh “the utility and integrity of the patent system . . . when deciding whether to institute AIA petitions.”

  1. CA Gov. Newsom Announces Budget Approval for Biosimilar Insulin Initiative

In July, we reported that California’s approved budget included a $100 million allotment to “contract to make [its] own insulin at a cheaper price, close to at cost.”  The budget designates $50 million for the development of biosimilar insulin products and the remaining $50 million to build an insulin manufacturing facility in California.  Governor Newsom explained that the budget allocation is a step toward implementing Executive Order N-01-19, which he signed in 2019 “to put California on the path towards creating [its] own prescription drugs.”   Further details on the initiative appear in a summary of the enacted budget prepared by Gov. Newsom’s office under the sub-header “CalRX Biosimilar Insulin Initiative.”

  1. European Regulatory Heads Make Biosimilars Interchangeable

In September, we reported that the European Medicines Agency’s (“EMA”) Biosimilar Medicines working Party (“BMWP”) and the Heads of Medicines Working Party (“HMA”) issued a joint statement confirming that biosimilar medicines approved in the European Union (“EU”) are interchangeable with their reference medicine or with an equivalent biosimilar.  The Joint Statement marks the first time that the EMA has taken an official position on interchangeability and harmonizes the approach already practiced in many Member States.  It also clarifies that decisions regarding automatic substitution at pharmacy-level (i.e., dispensing an interchangeable medicine instead of the reference product without consulting the prescriber), will be managed by individual member states.  The EMA’s position stands in contrast to the FDA’s, which requires that biosimilars meet additional requirements to be classified as interchangeable.

  1. President Biden Signs Executive Order for Advancing Biotechnology and Biomanufacturing Innovation

In September, we reported that President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”  The work undertaken pursuant to the Executive Order is referred to as the National Biotechnology and Biomanufacturing Initiative (or, NBBI).

In order to achieve the objectives of the Executive Order, the Biden Administration plans to, amongst other action items, “(b) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation, while adhering to principles of security, privacy, and responsible conduct of research; (c)  improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”

  1. China Approves World’s First Denosumab Biosimilar

In November, we reported Luye Pharma Group’s announcement that China’s National Medical Products Administration had approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.  Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive approval for a PROLIA®/XGEVA® (denosumab) biosimilar product.  Denosumab is a fully-human IgG2 monoclonal antibody that binds to RANKL and is used to treat osteoporosis including by reducing resorptive bone loss, increasing bone strength, and reducing fractures.  According to the press release, BOYOBEI® is also being developed for markets outside of China, including Europe and the United States, and will eventually seek marketing approval globally.