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Biosimilars Deals 2022

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Samsung Bioepis and Samil sign ranibizumab commercialisation agreement

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab).  Under the agreement, Samil is licenced to sell Amelivu® in Korea.  Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022.  Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.

Organon announces deal with Henlius for pertuzumab and denosumab

Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).  Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”.  The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).

Formycon and Athos announce closing of acquisition

Formycon and Athos KG announced closing of the acquisition by Formycon of 100% of the rights to FYB201 (biosimilar ranibizumab), a 50% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”.  The total value of the deal is €650M.

Aurobindo to acquire business and certain assets from Veritaz

Aurobindo announced that it will acquire certain business assets from Veritaz (the supplier of branded generic formulations and other health care products) for Rs 171 crore on a debt free basis.  The acquisition will support Aurobindo’s plans to manufacture biosimilars and other products in India.

The Juvenile Diabetes Research Foundation and Civica announce partnership for affordable biosimilar insulins

The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®).   Biosimilar insulins are to be developed for the US market so that low-cost insulin is supplied irrespective of insurance status from 2024.  JDRF is underwriting the initial development costs of the project, and Civica will manufacture and distribute biosimilar insulin for less than USD$30/vial, or $55/box of five pen cartridges.

AbbVie completes its acquisition of Syndesi Therapeutics SA

AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments.  This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portfolio, including lead molecule SDI-118, a small molecule which is currently in Ph Ib studies.

Biocon to acquire Viatris’ biosimilar assets

Biocon announced that it will acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash to create a vertically integrated biosimilars leader.  The transaction is expected to close in the second half of 2022, subject to conditions including certain regulatory approvals.  The subject business revenues are expected to be USD1billion in 2023 alone.

Alvotech and Fuji Pharma expand strategic partnership for Japan

Alvotech and Fuji Pharma announced that they have expanded their strategic partnership for Japan to include an undisclosed biosimilar currently in early phase development.  This brings the total number of products covered by the partnership to six.  Fuji will receive exclusive commercial rights to this biosimilar in Japan in exchange for upfront and milestone payments tied to development progression.  Alvotech will also receive a share of the in-market sales.

Bloomberg reports on industry interest in potential sale of Novartis’ Sandoz division

Bloomberg reported that the potential sale of Novartis’ Sandoz division has drawn a lot of interest from private equity as well as from other generics manufacturers.  Bloomberg reported that Blackstone Inc and Carlyle Group Inc are in talks to potentially team up on an offer, with other companies such as Advent International, Hellman & Friedman and KKR & Co said to be considering offers.  Novartis announced the potential sale of its Sandoz division in its Q3 2021 financial results and a decision on the future of Sandoz is expected by the end of 2022.

Dr Reddy’s announces agreement with Nimbus Health GmbH

Dr Reddy’s announced that it has entered into an agreement to acquire privately owned German medical cannabis company Nimbus Health GmbH.  Dr Reddy’s said that the acquisition will allow it to introduce medical cannabis-based medicines as a promising treatment option for patients.

Alvotech announces $21 million in additional commitments for private placement (PIPE) of Oaktree II common stock

Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common stock.  Alvotech and Oaktree Acquisition Corp. II previously announced in December 2021 that they had entered into a pre IPO merger agreement.  According to the announcement, the business combination is expected to deliver gross proceeds to Alvotech in excess of $475M.