SecProbe.io

Mail Stop 4720
December 11, 2015

Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512

Re: Oncobiologics, Inc.
Draft Registration Statement on Form S -1
Submitted November 16, 2015
CIK No. 0001649989

Dear Dr. Mohan :

We have reviewed your draft registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

Please respond t o this letter by providing the requested information and either submitting
an amended draft registration statement or  publicly  filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.

Overview, page 1

1. Please clarify the meaning of any significant scientific or technical terms the first time
they are used in your prospectus in order to ensure that lay readers will understand the
disclosure.  For example, please define each of the following at their first use:
 mAbs ;
 pharmacokinetic, or PK ; and
 PK bioequivalency criteria .

2. Your product pipeline table should highlight your product  candidate s in development that
are reasonably likely to result in an approved product in the foreseeable future. Research
and discovery activities that precede the identification of a product candidate are too

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 2

 remote to be highlighted in the pipeline table. Accordingly, please limit your table to
product  candidate s where you have se lected a clone for development .

3. Please include disclosure in your prospectus summary to state the approved therapeutic
use for the referenced product and for which indications you initially intend to seek
approval for your product candidates.  In addition , please disclose how the product is
intended to be delivered (e.g. pill formulation or injection).

Risk Associated with Our Business, page 3

4. Please supplement your list of bullet point risk factors to address the following:
 that, t o your knowledge, th ere has been only one biosimilar product application
approved by the FDA under the 351(k) pathway to date ;
 your reliance and the other material risks relating to your collaboration and
licensing agreements;  and
 that you have no issued patents, and the ris ks associated with any failure to obtain
and maintain protection of your own intellectual property.

The results of previous clinical trials may not be predictive of future results …, page 18

5. Please revise this risk factor to identify the indications for which you initially intend to
seek approval.  If you intend to extrapolate clinical data intended to support a
demonstration of biosimilarity in one indication  to support approval  of your biosimilar
candidate in one or more additional indications, please s o state, and describe the risks
related to such extrapolation.

We currently engage single source suppliers for clinical trial services , page 30

6. We note this risk factor discusses the risks associated with your multiple source suppliers
for fill -finish manufacturing and does not discuss the single source suppliers for clinical
trials.  In that regard, we refer to your last risk factor on page 28.  Please revise your
disclosure in this or a separate risk factor to discuss the risks relating to your sole supplier
for “specialty -manufactured bags.”  In addition, please disclose whether you believe
alternate sources of the specialty -manufactured bags ar e available.

If we infringe or are alleged to infringe intellectual property rights …, page 30

7. Please revise your disclosure to describe briefly the “ freedom to operate analyses ” in
layman’s terms.

We may be subject to claims that our employees …, pa ge 33

8. Please revise your disclosure to state that Genentech, former employer of Dr. Mohan and
Dr. Bahrt, developed bevacizumab (Avastin) , for which you seek to develop ONS -1045

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 3

 as a biosimilar, and trastuzumab (Herceptin) , for which you seek to develop ONS -1050
as a biosimilar.  In addition, please identify any similar circumstances that increase the
risk of the claims described in this risk factor.

Use of Proceeds, page 52

9. Please revise your Use of Proceeds to state w hether each of the allocated proceeds will
allow you to fund your clinical products and the expansion of your facility to completion.
If not, please describe how far in the trial process you anticipate the allocated proceeds
will allow you to reach for eac h of your product candidates  and the extent of your facility
expansion .

10. Please revise your Use of Proceeds table to separate the amounts to be used to fund
research and development activities from the amounts to be used for working capital  and
general cor porate purposes .

Collaboration and License Agreements
Huahai  — Humira (ONS -3010) and Avastin (ONS -1045), page 61

11. Please clarify whether the strategic license agreement with Huahai is the same as the co -
development and license agreement described here and  on page 86.  We may have
additional comments.

Collaboration Revenues, page 63

12. Please revise to quantify, in a tabular format, the components ( i.e. upfront fees,
milestones, deferred revenues, etc.) of your collaboration revenues for each period
presented.

Research and Development  Expenses , page 64

13. For each of your key research and development projects, please revise to disclose
research and deve lopment costs incurred during each period presented and inception to
date.  For the remainder of projects not considered individually significant, disclose the
composition of the total R&D expense for each period presented.  If you do not track
these costs  by project please revise your disclosure to clarify.

Stock -Based Compensation and PSU Obligation , page 68

14. We may have additional comments on your accounting for equity issuances including
stock compensation and beneficial conversion features. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between recent valuations of your common stock leading up to the IPO and the estimated
offering price.

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 4

 ONS -3010 – Adalimumab (Humira) Biosimilar, page 77

15. Please revise your disclosure to explain what “luminescence” is and how it demonstrates
potency.

16. Pleas e revise the table of most frequently reported adverse events on page 79 to clarify
what you mean by “Preferred Term.”

Our Product Candidate Portfolio , page 77

17. Please revise your disclosures for each of your clinical trials to state the jurisdiction and
the governing body pursuant to which the clinical trials were performed and where you
intend to perform your Phase 3 trials.  For example, if a clinical trial was conducted in the
United States pursuant to an IND issued from the FDA, please so state and in clude the
date of the IND.  In addition, include conforming disclosure in your prospectus summary.

Chemistry Manufacturing Controls, or CMC, Status , page 78

18. We note your disclosure that a novel formulation of similar stability was developed and
utilize d in the Phase 1 clinical trial .  Please revise your disclosure, if applicable, to
discuss whether you will be utilizing the same formulation in your Phase 3 trials and, if
not, describe whether you believe any such change will affect your Phase 3 trials.

Selexis  — Humira (ONS -3010), Avastin (ONS -1045) and Herceptin (ONS -1050) , page 82

19. We refer to your research license agreement, as amended.  Please revise your prospectus
to describe the material terms of this agreement , including :
 the initial fee;
 milestone payments;  and
 aggregate amounts paid to date.

Commercial License Agreements, page 83

20. We refer to your disclosure of your commercial licensing agreements.  For each of the
agreements, p lease revise your prospectus to describe the material terms , including:
 up-front or execution payments;
 milestone payments;
 royalty termination fees ; and
 aggregate amounts paid to date.

In addition, please file the se agreement s as exhibit s in accordance with Item 601 of
Regulation S -K.

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 5

 IPCA   — Humira (ONS -3010), Avastin (ONS -1045) and Herceptin (ONS -1050) , page 83

21. We refer to each of your license agreements described on pages 83 and 84.   Please revise
your prospectus to describe the material terms of each of the agreement s, including :
 up-front or execution payments;
 milestone  payment s;
 royalty rates within 10% (e.g. low teens, twenties, etc.);
 development payments;
 commercialization fees ; and
 aggregate amounts received to date.

In addition, please file the agreement s as e xhibit s in accordance with Item 601 of
Regulation S -K.

Liomont  — Humira (ONS -3010) and Avastin (ONS -1045) , page 84

22. Please revise your prospectus to describe the material t erms of your agreement,
including:
 the up-front or execution payment;
 milestone paymen ts; and
 royalty rates within 10% (e.g. low teens, twenties, etc.) .

In addition, please file the agreement as an exhibit in accordance with Item 601 of
Regulation S -K.

Huahai  — Humira (ONS -3010) and Avastin (ONS -1045)
Co-Development and License Agreeme nt…page 86

23. Please revise your prospectus to describe the material terms of the license agreement ,
including:
 the up-front or execution payment;  and
 milestone  payment s.

In addition, please file the agreement as an exhibit in accordance with Item 601 of
Regulation S -K.

Intellectual Property, page 87

24. Please revise your disclose to identify the applicable jurisdictions and the anticipated
patent expiration dates  for each  of your patent applications.

25. We refer to your “Collaboration and License Agreements” on page 82.  We note that you
are currently licensing rights to the Selexis Technology  pursuant to your agreements with

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 6

 Selexis.  Please revise your disclosure in this s ection to  describe any material patents and
patent applications that you  license , including:
 nature of the patent and the type of patent protection such as composition of matter, use
or process; and
 patent expiration dates or expected expiration dates for  patent applications by
jurisdiction.

Compensation Committee Interlocks and Insider Participation, page 99

26. We refer to your disclosure that none of your  executive officers currently serves, or has
served during the last year, as a member of the board of  directors or compensation
committee of any entity that has one or more executive officers serving as a member of
our board of directors or compensation committee .  We refer to each of the biographical
disclosures for Dr. Mohan and Mr. Griffith and their r espective positions with Sonnet
Biotherapuetics, Inc.  Please tell us why you believe Dr. Mohan and Mr. Griffith do not
meet the disclosure requirements of this section.  In the alternative, please revise this
section to provide the relevant disclosures fo r Dr. Mohan and Mr. Griffith

Agreement with Named Executive Officers, page 103

27. Please revise your disclosure for each of your named executive officers to disclose
whether each agreement is for full or part -time services, whether the named executive
officer is currently performing their duties on a full or part time basis, term and
termination provisions.

Loans and Guarantees, page 116

28. Please revise your description of the amounts owed to Dr. Mohan to disclose any interest
accruing on such amounts.

Other Comments

29. Please submit all exhibits as soon as practicable. We may have furt her comments upon
examination of these exhibits.

30. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus.  If those are not the only graphics, please
provide any additional graphics prior to their use for our review.

31. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.

Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 7

   You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statemen ts and related matters.  Please
contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer  at (202) 551 -3793, or me at
(202) 551 -3675 with any other questions.

Sincerely,

      /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc: Via E -mail
 Yvan -Claude Pierre
 Cooley LLP